A Study of Anti-CD19 CAR T-cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis

2024-511168-10-00 Protocol KYV101-007 Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 4 EU/EEA countries · 10 sites · Protocol KYV101-007

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 134
Countries 4
Sites 10

Primary or Secondary Progressive Multiple Sclerosis

1. To evaluate the efficacy of KYV-101

Key facts

Sponsor
Kyverna Therapeutics Inc.
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20], Diseases [C] - Nervous System Diseases [C10]
Decision date (initial)
2024-10-07
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Kyverna Therapeutics, Inc.

External identifiers

EU CT number
2024-511168-10-00
ClinicalTrials.gov
NCT06384976

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Safety, Efficacy

1. To evaluate the efficacy of KYV-101

Secondary objectives 4

  1. 2a. To characterize the safety and tolerability of KYV-101
  2. 2b. To further evaluate the efficacy of KYV-101
  3. 2c. To characterize the PK and PD of KYV-101
  4. 2d. To evaluate the immunogenicity (humoral) of KYV-101

Conditions and MedDRA coding

Primary or Secondary Progressive Multiple Sclerosis

VersionLevelCodeTermSystem organ class
26.1 PT 10053395 Progressive multiple sclerosis 100000004852
21.0 PT 10029202 Nervous system disorder 100000004852

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Phase 2 Open-Label, Randomized Study
Open-label, randomized, efficacy, and safety study of KYV-101 (a fully human anti-CD19 CAR T-cell therapy) in adult subjects with PPMS or SPMS refractory to anti-CD20 monoclonal antibody (mAb) treatment.
 Randomised Controlled Single [{"id":82035,"code":2,"name":"Investigator"}] Active (KYV-101): Subjects will be randomized in a 1:1 ratio to KYV-101 or to continuing anti-CD20 mAb.
Control (anti-CD20 mAb): Subjects will be randomized in a 1:1 ratio to KYV-101 or to continuing anti-CD20 mAb.

Regulatory references

Scientific advice from competent authorities
Paul-Ehrlich-Institut
Plan to share IPD
No
EU CT numberTitleSponsor
2022-003686-38 A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis
2023-509892-17-00 A Phase 2, Open-Label, Multicentre Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Generalized Myasthenia Gravis (KYSA-6) Kyverna Therapeutics Inc.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Subject must be 18 to 60 years of age (inclusive).
  2. Subject must have a history of diagnosis of PPMS or SPMS
  3. History of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months with documented evidence of clinical disability progression within the 2 years prior to inclusion. Patients with active SPMS should also have shown inadequate response or intolerance to another DMT (e.g., sphingosine-1-phosphate (S1P) receptor modulator), subject to availability.

Exclusion criteria 2

  1. Monophasic disease, radiologically isolated syndrome, clinically isolated syndrome, progressive solitary sclerosis or relapsing-remitting disease as defined by the 2017 McDonald criteria (Thompson 2018).
  2. History of neuromyelitis optica spectrum disorder (NMOSD) or myelin oligodendrocyte glycoprotein (MOG) antibody associated disease (MOGAD).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 1. Confirmed disability progression, defined as an increase in the EDSS

Secondary endpoints 9

  1. 2a. Incidence and severity of AEs, AESIs, and SAEs
  2. 2b1. Composite Confirmed Disability Progression (CCPD) defined as disability progression measured by EDSS
  3. 2b2. Impact on clinical disability as defined by the number of days from randomization to the primary outcome.
  4. 2b3. Disability as measured by EDSS change from pretreatment baseline to end of study.
  5. 2b4. Annualized relapse rate (ARR) in patients with active SPMS (relapse in the past 2 years or active lesions on MRI)
  6. 2b5. Comparison of end-of-study brain MRI compared to baseline scan in T2 burden of demyelinating disease, baseline to end of study, including whole brain volume and grey matter volume changes from treatment baseline to end of study.
  7. 2b6. For the CSF consenting subset, comparison of interval changes in unmatched intrathecal oligoclonal bands treatment from baseline to end of study.
  8. 2c. CAR-positive T-cell counts, CAR transgene level, B-cell counts over time, systemic cytokine concentrations.
  9. 2d. Presence of anti-KYV-101 antibodies.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

KYV-101

PRD9974051 · Product

Active substance
KYV-101
Pharmaceutical form
SUSPENSION
Route of administration
INTRAVENOUS
Max daily dose
33000000 DF dosage form
Max total dose
100000000 DF dosage form
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
ATC code
NOTASSIGN — -
MA holder
KYVERNA THERAPEUTICS INC.
Paediatric formulation
No
Orphan designation
No

Comparator 40

Kesimpta 20 mg solution for injection in pre-filled syringe

PRD8833236 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/002
MA holder
NOVARTIS IRELAND LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled syringe

PRD8833238 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/002
MA holder
NOVARTIS IRELAND LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled syringe

PRD8833237 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/002
MA holder
NOVARTIS IRELAND LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled syringe

PRD8833239 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/002
MA holder
NOVARTIS IRELAND LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833240 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/003
MA holder
NOVARTIS IRELAND LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833241 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/003
MA holder
NOVARTIS IRELAND LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833242 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/003
MA holder
NOVARTIS IRELAND LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled syringe

PRD8833232 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/001
MA holder
NOVARTIS IRELAND LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled syringe

PRD8833233 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/001
MA holder
NOVARTIS IRELAND LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled syringe

PRD8833234 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/001
MA holder
NOVARTIS IRELAND LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled syringe

PRD8833235 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/001
MA holder
NOVARTIS IRELAND LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833243 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/003
MA holder
NOVARTIS IRELAND LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833244 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/004
MA holder
NOVARTIS IRELAND LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833245 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/004
MA holder
NOVARTIS IRELAND LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833246 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/004
MA holder
NOVARTIS IRELAND LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833247 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/004
MA holder
NOVARTIS IRELAND LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ocrevus 300 mg concentrate for solution for infusion

PRD5771884 · Product

Active substance
Ocrelizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
600 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AA36 — -
Marketing authorisation
EU/1/17/1231/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ocrevus 300 mg concentrate for solution for infusion

PRD5771907 · Product

Active substance
Ocrelizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
600 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AA36 — -
Marketing authorisation
EU/1/17/1231/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ocrevus 300 mg concentrate for solution for infusion

PRD5771906 · Product

Active substance
Ocrelizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
600 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AA36 — -
Marketing authorisation
EU/1/17/1231/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ocrevus 300 mg concentrate for solution for infusion

PRD5846328 · Product

Active substance
Ocrelizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
600 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AA36 — -
Marketing authorisation
EU/1/17/1231/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ocrevus 300 mg concentrate for solution for infusion

PRD5771885 · Product

Active substance
Ocrelizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
600 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AA36 — -
Marketing authorisation
EU/1/17/1231/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ocrevus 300 mg concentrate for solution for infusion

PRD5771848 · Product

Active substance
Ocrelizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
600 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AA36 — -
Marketing authorisation
EU/1/17/1231/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ocrevus 300 mg concentrate for solution for infusion

PRD5771912 · Product

Active substance
Ocrelizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
600 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AA36 — -
Marketing authorisation
EU/1/17/1231/002
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ocrevus 300 mg concentrate for solution for infusion

PRD5846329 · Product

Active substance
Ocrelizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
600 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04AA36 — -
Marketing authorisation
EU/1/17/1231/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MabThera 100 mg concentrate for solution for infusion

PRD2159876 · Product

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
5 g gram(s)
Max treatment duration
42 Month(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/98/067/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MabThera 100 mg concentrate for solution for infusion

PRD2154041 · Product

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
5 g gram(s)
Max treatment duration
42 Month(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/98/067/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MabThera 100 mg concentrate for solution for infusion

PRD2159285 · Product

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
5 g gram(s)
Max treatment duration
42 Month(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/98/067/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MabThera 500 mg concentrate for solution for infusion

PRD2154043 · Product

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
5 g gram(s)
Max treatment duration
42 Month(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/98/067/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MabThera 500 mg concentrate for solution for infusion

PRD2159886 · Product

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
5 g gram(s)
Max treatment duration
42 Month(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/98/067/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MabThera 500 mg concentrate for solution for infusion

PRD2159307 · Product

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
5 g gram(s)
Max treatment duration
42 Month(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/98/067/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MabThera 100 mg concentrate for solution for infusion

PRD398760 · Product

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
5 g gram(s)
Max treatment duration
42 Month(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/98/067/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MabThera 500 mg concentrate for solution for infusion

PRD398759 · Product

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
5 g gram(s)
Max treatment duration
42 Month(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/98/067/002
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Briumvi 150 mg concentrate for solution for infusion

PRD10879779 · Product

Active substance
Ublituximab
Substance synonyms
Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
450 mg milligram(s)
Max total dose
2.25 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04 — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
EU/1/23/1730/001
MA holder
NEURAXPHARM PHARMACEUTICALS S.L.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Briumvi 150 mg concentrate for solution for infusion

PRD10889560 · Product

Active substance
Ublituximab
Substance synonyms
Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
450 mg milligram(s)
Max total dose
2.25 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04 — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
EU/1/23/1730/001
MA holder
NEURAXPHARM PHARMACEUTICALS S.L.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Briumvi 150 mg concentrate for solution for infusion

PRD10889562 · Product

Active substance
Ublituximab
Substance synonyms
Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
450 mg milligram(s)
Max total dose
2.25 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04 — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
EU/1/23/1730/001
MA holder
NEURAXPHARM PHARMACEUTICALS S.L.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Briumvi 150 mg concentrate for solution for infusion

PRD11158235 · Product

Active substance
Ublituximab
Substance synonyms
Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
450 mg milligram(s)
Max total dose
2.25 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04 — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
EU/1/23/1730/002
MA holder
NEURAXPHARM PHARMACEUTICALS S.L.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Briumvi 150 mg concentrate for solution for infusion

PRD11158237 · Product

Active substance
Ublituximab
Substance synonyms
Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
450 mg milligram(s)
Max total dose
2.25 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04 — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
EU/1/23/1730/002
MA holder
NEURAXPHARM PHARMACEUTICALS S.L.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Briumvi 150 mg concentrate for solution for infusion

PRD10889561 · Product

Active substance
Ublituximab
Substance synonyms
Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
450 mg milligram(s)
Max total dose
2.25 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04 — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
EU/1/23/1730/001
MA holder
NEURAXPHARM PHARMACEUTICALS S.L.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Briumvi 150 mg concentrate for solution for infusion

PRD11158239 · Product

Active substance
Ublituximab
Substance synonyms
Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
450 mg milligram(s)
Max total dose
2.25 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04 — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
EU/1/23/1730/002
MA holder
NEURAXPHARM PHARMACEUTICALS S.L.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Briumvi 150 mg concentrate for solution for infusion

PRD11158233 · Product

Active substance
Ublituximab
Substance synonyms
Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
450 mg milligram(s)
Max total dose
2.25 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L04 — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
EU/1/23/1730/002
MA holder
NEURAXPHARM PHARMACEUTICALS S.L.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kyverna Therapeutics Inc.

4 Total trials 2 Recruiting 1 Ended
Commercial
Sponsor organisation
Kyverna Therapeutics Inc.
Address
5980 Horton Street Ste 550
City
Emeryville
Postcode
94608-2045
Country
United States

Scientific contact point

Organisation
Kyverna Therapeutics Inc.
Contact name
Medical Kyverna

Public contact point

Organisation
Kyverna Therapeutics Inc.
Contact name
Medical Kyverna

Third parties 15

OrganisationCity, countryDuties
Pra International
ORG-100032850
 Lenexa, United States Laboratory analysis
Neurorx Research Inc.
ORG-100046079
 Montreal, Canada Other
Precision For Medicine Inc.
ORG-100041895
 Houston, United States Laboratory analysis
Scout Clinical
ORG-100042228
 Dallas, United States Other
4G Clinical B.V.
ORG-100044721
 Amsterdam, Netherlands Interactive response technologies (IRT)
Icon (Lr) Limited
ORG-100042612
 Dublin 18, Ireland Laboratory analysis
Molecularmd Corp.
ORG-100047559
 Portland, United States Laboratory analysis
Icon Laboratory Services Inc.
ORG-100037135
 Farmingdale, United States Laboratory analysis
PPD Development LP
ORG-100011560
 Wilmington, United States On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Interactive response technologies (IRT), Code 5, Data management, E-data capture, Code 8, Code 9
Medidata Solutions Inc.
ORG-100016256
 New York, United States Data management, E-data capture
Labcorp Central Laboratory Services SARL
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Precision For Medicine Inc.
ORG-100041895
 Frederick, United States Code 5
Pharmaceutical Research Associates Group B.V.
ORG-100006268
 Assen, Netherlands Laboratory analysis
PPD Global Central Labs
ORG-100046496
 Zaventem, Belgium Laboratory analysis
Wuxi Advanced Therapies Inc.
ORG-100032133
 Philadelphia, United States Other

Locations

4 EU/EEA countries · 10 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Authorised, recruitment pending 10 1
Belgium Authorised, recruitment pending 3 1
Germany Authorised, recruitment pending 70 7
Italy Authorised, recruitment pending 5 1
Rest of world
United States
 — 46 —

Investigational sites

Austria

1 site · Authorised, recruitment pending
Medical University Of Vienna
University Clinic for Transfusion Medicine and Cell Therapy, Waehringer Guertel 18-20, Alsergrund, Vienna

Belgium

1 site · Authorised, recruitment pending
Antwerp University Hospital
Neurology, Drie Eikenstraat 655, 2650, Edegem

Germany

7 sites · Authorised, recruitment pending
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation, Martinistrasse 52, Eppendorf, Hamburg
Klinikum rechts der Isar der TU Muenchen AöR
3. Medizinische Klinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
Charite Universitaetsmedizin Berlin KöR
Department of Neurology, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Jena KöR
Klinik für Neurologie, Am Klinikum 1, Lobeda, Jena
Medizinische Hochschule Hannover
Klinik für Neurologie mit Klinischer Neurophysiologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Katholisches Klinikum Bochum gGmbH
Neurologische Universitätsklinik, Gudrunstrasse 56, Grumme, Bochum
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Italy

1 site · Authorised, recruitment pending
Ospedale San Raffaele S.r.l.
Neurology Unit, Via Olgettina 60, 20132, Milan

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-05-24 Germany Acceptable
2024-09-30
 2024-10-01

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