Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
11
Countries
2
Sites
4
Acute Myeloid Leukemia
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
- 8 Nov 2022 → 19 May 2024
- Decision date (initial)
- 2023-10-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507748-35-00
- EudraCT number
- 2020-000962-40
- ClinicalTrials.gov
- NCT04789408
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemia
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 |
|---|---|---|---|
| France | Ended | 5 | 2 |
| Germany | Ended | 5 | 2 |
| Rest of world
United States
|
— | 1 | — |
Investigational sites
Institut Paoli-Calmettes
Hematology Department, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology Department, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin III - Bone Marrow Transplantation Unit, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Frankfurt AöR
Med. Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
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 | 2022-11-08 | 2023-10-10 | 2024-03-19 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-22 | Germany | Acceptable 2023-10-04
|
2023-10-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-13 | Germany | No conclusion 2024-07-01
|
2024-07-02 |