Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
183
Countries
4
Sites
14
Relapsed/Refractory Mantle Cell Lymphoma
To evaluate the efficacy of KTE-X19, as measured by objective response rate (ORR), in subjects with r/r MCL
Key facts
- Sponsor
- Kite Pharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Jul 2018 → 18 Jun 2025
- Decision date (initial)
- 2023-12-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Kite Pharma Inc.
External identifiers
- EU CT number
- 2023-506641-35-00
- EudraCT number
- 2015-005008-27
- ClinicalTrials.gov
- NCT02601313
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy of KTE-X19, as measured by objective response rate (ORR), in subjects with r/r MCL
Secondary objectives 3
- To assess the safety and tolerability of KTE-X19
- Patient-reported outcomes (PROs) in Cohort 1 and Cohort 2 will include change in the European Quality of Life-5 Dimensions (EQ-5D) scores from baseline to Month 6
- PROs in Cohort 3 will include change in EQ-5D and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) scores from baseline over time.
Conditions and MedDRA coding
Relapsed/Refractory Mantle Cell Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10026801 | Mantle cell lymphoma refractory | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy. Individuals must not have received prior therapy with a BTKi.
- At least 1 measurable lesion
- Platelet count ≥ 75,000/uL
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/min
- Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA), and no clinically significant electrocardiogram (ECG) findings
- Baseline oxygen saturation > 92% on room air
Exclusion criteria 3
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- ORR (complete response [CR] + partial response [PR]) per the Lugano Classification per Independent Radiology Review Committee (IRRC) review
Secondary endpoints 11
- DOR
- Best objective response (BOR)
- ORR as determined by study investigators
- Progression-free survival
- Overall survival
- Incidence of adverse events (AEs) and clinically significant changes in laboratory values
- Incidence of anti-CD19 CAR antibodies
- Levels of anti-CD19 CAR T cells in blood
- Levels of cytokines in serum
- Changes over time in the EQ-5D scale score and visual analogue scale score
- Changes over time in the EORTC-QLQ-C30 score (Cohort 3 only)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Tecartus 0.4 - 2 x 10e8 cells dispersion for infusion
PRD8604659 · Product
- Active substance
- Brexucabtagene Autoleucel
- Substance synonyms
- AUTOLOGOUS PERIPHERAL BLOOD T CELLS CD4 AND CD8 SELECTED AND CD3 AND CD28 ACTIVATED TRANSDUCED WITH RETROVIRAL VECTOR EXPRESSING ANTI-CD19 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR AND CULTURED, KTE-X19
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XL06 — -
- Marketing authorisation
- EU/1/20/1492/001
- MA holder
- KITE PHARMA EU B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2344
- Modified vs. Marketing Authorisation
- No
Auxiliary 11
Methylprednisolone 1000 mg powder and solvent for solution for injection/infusion
PRD10716811 · Product
- Active substance
- Methylprednisolone
- Substance synonyms
- 6-METHYLPREDNISOLONE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- PL 51463/0128
- MA holder
- KENT PHARMA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMBRUVICA 140 mg hard capsules
PRD1729387 · Product
- Active substance
- Ibrutinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 560 mg milligram(s)
- Max total dose
- 14000 mg milligram(s)
- Max treatment duration
- 25 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EL01 — -
- Marketing authorisation
- EU/1/14/945/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD931324 · Product
- Active substance
- Diphenhydramine Hydrochloride
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL AND IV
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R06AA02 — DIPHENHYDRAMINE
- Marketing authorisation
- PL 00386/5008R
- MA holder
- NORMA CHEMICALS LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cyclophosphamide 500 mg Powder for Solution for Injection or Infusion
PRD1649348 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 2 gm/m2 gram(s)/square meter
- Max total dose
- 4 gm/m2 gram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- PL 04416/1393
- MA holder
- SANDOZ LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154620 · Product
- Active substance
- Tocilizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 2400 mg milligram(s)
- Max total dose
- 3200 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD7227714 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL AND IV
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 12762/0618
- MA holder
- MERCURY PHARMACEUTICALS LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Panadol 500 mg Film Coated Tablets
PRD303825 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 650 mg milligram(s)
- Max total dose
- 650 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- PA 678/107/1
- MA holder
- HALEON IRELAND LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion
PRD1794909 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 90 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- PL 20075/0379
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cytarabine 20 mg/ml Solution for Injection or Infusion
PRD1171080 · Product
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 2 gm/m2 gram(s)/square meter
- Max total dose
- 4 gm/m2 gram(s)/square meter
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- PA 0822/200/001
- MA holder
- PFIZER HEALTHCARE IRELAND
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Calquence 100 mg hard capsules
PRD8485701 · Product
- Active substance
- Acalabrutinib
- Substance synonyms
- ACP-196, (S)-4-(8-AMINO-3-(1-BUT-2-YNOYLPYRROLIDIN-2-YL)-IMIDAZO[1,5-Α]PYRAZIN-1-YL)-N-(PYRIDIN-2-YL)-BENZAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 5000 mg milligram(s)
- Max treatment duration
- 25 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EL02 — -
- Marketing authorisation
- EU/1/20/1479/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD649953 · Product
- Active substance
- Mesna
- Substance synonyms
- SODIUM 2-MERCAPTOETHANESULPHONATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 540 mg milligram(s)
- Max total dose
- 1620 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AF01 — MESNA
- Marketing authorisation
- PL 00116/0395
- MA holder
- BAXTER HEALTHCARE LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kite Pharma Inc.
- Sponsor organisation
- Kite Pharma Inc.
- Address
- 2400 Broadway
- City
- Santa Monica
- Postcode
- 90404-3030
- Country
- United States
Scientific contact point
- Organisation
- Kite Pharma Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Kite Pharma Inc.
- Contact name
- EU CT Support
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Ur Medicine Central Laboratory ORG-100048827
|
West Henrietta, United States | Other, Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 12, Other, Code 2, Code 9 |
| Imaging Endpoints II LLC ORG-100045399
|
Scottsdale, United States | Other |
Locations
4 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 13 | 5 |
| Germany | Ended | 11 | 3 |
| Netherlands | Ended | 30 | 3 |
| Spain | Ended | 14 | 3 |
| Rest of world
United Kingdom, United States
|
— | 115 | — |
Investigational sites
Centre Hospitalier Universitaire De Rennes
Department of Clinical Hematology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Bordeaux
Department of Clinical Hematology and Cell Therapy, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Lyon Sud
Department of Clinical Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Hopital Saint Louis
Oncology Haematology Department, 1 Avenue Claude Vellefaux, 75010, Paris
Hopital Saint Eloi
Department of Clinical Hematology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Universitaetsklinikum Wuerzburg AöR
Med. Klinik und Poliklinik II, Zentrum Innere Medizin, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik III, Marchioninistrasse 15, Hadern, Munich
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
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 |
|---|---|---|---|---|---|
| France | 2018-12-17 | 2025-05-20 | 2018-12-17 | 2023-04-20 | |
| Germany | 2019-02-25 | 2025-05-08 | 2019-02-25 | 2023-04-19 | |
| Netherlands | 2018-07-09 | 2025-05-06 | 2018-07-09 | 2023-04-19 | |
| Spain | 2021-11-05 | 2025-06-17 | 2021-12-23 | 2023-04-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-506641-35_Redacted | 9 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2023-506641-35 | 9 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-506641-35 | 9 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-506641-35 | 9 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2023-506641-35 | 9 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-17 | Spain | Acceptable 2023-12-19
|
2023-12-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-27 | Spain | Acceptable 2024-05-29
|
2024-05-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-15 | Spain | Acceptable 2025-03-04
|
2025-03-04 |