Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
173
Countries
2
Sites
4
Relapsed and/or Refractory B-cell Lymphoma
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
- 6 Dec 2024 → ongoing
- Decision date (initial)
- 2024-06-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511616-24-00
- EudraCT number
- 2020-000562-41
- ClinicalTrials.gov
- NCT04989803
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed and/or Refractory B-cell Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10003903 | B-cell lymphoma refractory | 100000004864 |
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
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 10 | 1 |
| Netherlands | Ongoing, recruiting | 15 | 3 |
| Rest of world
Canada, United States, United Kingdom, Australia
|
— | 148 | — |
Investigational sites
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik Und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
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 | 2023-12-01 | 2024-01-03 | 2024-12-04 | ||
| Netherlands | 2023-05-17 | 2024-03-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-64120
- Halt date
- 2024-12-04
- Member states concerned
- Netherlands
- Publication date
- 2024-12-19
- Reason
- Study management related
- Explanation
- Please refer to attached document
- Follow-up measures
- Please refer to attached document
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-64121
- Halt date
- 2024-12-04
- Member states concerned
- Germany
- Publication date
- 2024-12-19
- Reason
- Study management related
- Explanation
- Please refer to attached document
- Follow-up measures
- Please refer to attached document
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-26 | Germany | Acceptable 2024-05-28
|
2024-05-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-19 | Germany | Acceptable 2024-10-28
|
2024-10-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-08 | Germany | Acceptable 2025-01-08
|
2025-01-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-17 | Germany | Acceptable 2025-04-22
|
2025-04-24 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-30 | Germany | Acceptable 2025-09-22
|
2025-09-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-16 | Germany | Acceptable 2026-04-27
|
2026-04-28 |