Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
130
Countries
1
Sites
1
Lupus Nephritis
To evaluate long-term safety following treatment with KYV-101
Key facts
- Sponsor
- Kyverna Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 24 Mar 2026 → ongoing
- Decision date (initial)
- 2026-03-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Kyverna Therapeutics Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate long-term safety following treatment with KYV-101
Conditions and MedDRA coding
Lupus Nephritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
| 21.1 | PT | 10025140 | Lupus nephritis | 100000004857 |
| 21.1 | PT | 10028417 | Myasthenia gravis | 100000004852 |
| 21.0 | LLT | 10042953 | Systemic sclerosis | 10028395 |
| 20.0 | PT | 10072148 | Stiff person syndrome | 100000004852 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Enrollment All participants who received at least 1 infusion of KYV-101 while participating in a previous
KYV-101 treatment clinical study will be asked to participate in this LTFU protocol upon
completion or early discontinuation from the prior parent treatment protocol.
|
Not Applicable | None | ||
| 2 | Months 3, 6, 12, and 18 (From the Last Dose of KYV-101) Participants will have a different schedule of assessments depending on their primary study ranging from quarterly to yearly visits.
|
Not Applicable | None | ||
| 3 | Years 1 to 5 Participants who consent to enroll in this study will have annual laboratory evaluations and safety
assessments conducted during the first 5 years on study
|
Not Applicable | None | ||
| 4 | Years 6 to 15 Following the 5-year (Month 60) visit, participants will be contacted annually (±1 month) by
telephone or written questionnaire to Year 15, consistent with health authority guidance
(FDA 2020).
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- Paul-Ehrlich-Institut
- Plan to share IPD
- No
- IPD plan description
- Not Applicable
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513329-22-00 | 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 (KYSA-3) | Kyverna Therapeutics Inc. |
| 2024-514955-13-00 | COMparison of B-cell dePletion by rituximAb and anti-CD 19 CAR-T therapy in patients with rhEumatoid arthritis- The COMPARE TRIAL TWO - STAGE INTERVENTIONAL, PROSPECTIVE, RANDOMIZED, CONTROLLED, OPEN LABEL, PARALLEL - GROUP PHASE I/II TRIAL IN PATIENTS WITH ACTIVE, ACPA – POSITIVE AND TREATMENT REFRACTORY RHEUMATOID ARTHRITIS | Charite Universitaetsmedizin Berlin KöR |
| 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 1
- Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol
Exclusion criteria 1
- Not Applicable
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assesse by ddPCR - Incidence of RCL by qPCR
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9974051 · Product
- Active substance
- KYV-101
- Pharmaceutical form
- SUSPENSION
- Route of administration
- INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 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
- Yes
- Orphan designation number
- EMA/OD/0000246991
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kyverna Therapeutics Inc.
- 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 7
| Organisation | City, country | Duties |
|---|---|---|
| Icon (Lr) Limited ORG-100042612
|
Dublin 18, Ireland | Other, Laboratory analysis |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 10, Code 11, Code 12, Code 2, Interactive response technologies (IRT), Code 5, Data management, E-data capture, Code 8, Code 9 |
| Precision For Medicine Inc. ORG-100041895
|
Houston, United States | Other, Laboratory analysis |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Assen, Netherlands | Other, Laboratory analysis |
| Molecularmd Corp. ORG-100047559
|
Portland, United States | Other, Laboratory analysis |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 30 | 1 |
| Rest of world
Brazil, United States
|
— | 100 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2026-03-24 | 2026-03-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Kyverna_ KYV101-004_Protocol Clarification Letter_2024-511198-31-00_Public | N/A |
| Protocol (for publication) | D1_Kyverna_ KYV101-004_Protocol_2024-511198-31-00_Public | 3.0 |
| Protocol (for publication) | D4_Kyverna_ KYV101-004_MG-ADL_DEU_Public | 1.1 |
| Protocol (for publication) | D4_Kyverna_ KYV101-004_MG-ADL_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_KYV-101-004_Recruitment-Informed-Consent_Procedure_DEU | 1.0 |
| Subject information and informed consent form (for publication) | L1_KYV101-004_Main_ICF_DEU_DEU_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KYV101-004_Optional Future Research_ICF_DEU_DEU_Public | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-28 | Germany | Acceptable 2026-03-06
|
2026-03-06 |