Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
6
Countries
1
Sites
2
Application of the autologous CAR T cells (Tarcidomgen Kimleucel) in the treatment of refractory and relapsed CD19+ B cell neoplasms
Key facts
- Sponsor
- Famicordtx S.A., Polski Bank Komorek Macierzystych Sp. z o.o.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 30 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520653-37-00
- EudraCT number
- 2021-005720-37
- ClinicalTrials.gov
- NCT06593145
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Application of the autologous CAR T cells (Tarcidomgen Kimleucel) in the treatment of refractory and relapsed CD19+ B cell neoplasms
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10076867 | Acute lymphocytic leukemia refractory | 10029104 |
| 21.0 | PT | 10012822 | Diffuse large B-cell lymphoma refractory | 100000004864 |
| 21.1 | PT | 10026801 | Mantle cell lymphoma refractory | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Famicordtx S.A.
- Sponsor organisation
- Famicordtx S.A.
- Address
- Ul Dzialkowa 85
- City
- Warsaw
- Postcode
- 02-234
- Country
- Poland
Scientific contact point
- Organisation
- Famicordtx S.A.
- Contact name
- CARLA punkt kontaktowy
Public contact point
- Organisation
- Famicordtx S.A.
- Contact name
- CARLA punkt kontaktowy
Polski Bank Komorek Macierzystych Sp. z o.o.
- Sponsor organisation
- Polski Bank Komorek Macierzystych Sp. z o.o.
- Address
- Aleja Jana Pawla II 29
- City
- Warsaw
- Postcode
- 00-867
- Country
- Poland
Scientific contact point
- Organisation
- Famicordtx S.A.
- Contact name
- Natalia Żmijewska
Public contact point
- Organisation
- Famicordtx S.A.
- Contact name
- Natalia Żmijewska
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 6 | 2 |
| Rest of world | — | 0 | — |
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 |
|---|---|---|---|---|---|
| Poland | 2025-01-30 | 2025-01-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-15 | Poland | Acceptable 2025-01-29
|
2025-01-30 |