Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
36
Countries
2
Sites
5
Advanced Hepatocellular Carcinoma (HCC) that is not amenable to transplant or resection. Loco-regional therapy is allowed until lymphodepletion.
Key facts
- Sponsor
- Adaptimmune LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Feb 2018 → 5 Sep 2025
- Decision date (initial)
- 2024-09-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514437-37-00
- EudraCT number
- 2017-000778-12
- ClinicalTrials.gov
- NCT03132792
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Hepatocellular Carcinoma (HCC) that is not amenable to transplant or resection. Loco-regional therapy is allowed until lymphodepletion.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10062476 | Neuroendocrine tumor | 10029104 |
| 20.1 | LLT | 10017770 | Gastric carcinoma | 10029104 |
| 21.0 | LLT | 10019828 | Hepatocellular carcinoma non-resectable | 10029104 |
| 27.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
| 20.0 | LLT | 10025044 | Lung cancer | 10029104 |
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 21.0 | LLT | 10033604 | Pancreatic cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Adaptimmune LLC
- Sponsor organisation
- Adaptimmune LLC
- Address
- 351 Rouse Boulevard
- City
- Philadelphia
- Postcode
- 19112-1903
- Country
- United States
Scientific contact point
- Organisation
- Adaptimmune LLC
- Contact name
- Regulatory Affairs
Public contact point
- Organisation
- Adaptimmune LLC
- Contact name
- Regulatory Affairs
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 6 | 3 |
| Spain | Ended | 8 | 2 |
| Rest of world
United Kingdom, United States
|
— | 22 | — |
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 |
|---|---|---|---|---|---|
| France | 2020-02-17 | 2024-12-05 | 2020-04-02 | 2021-11-17 | |
| Spain | 2018-02-22 | 2025-09-04 | 2018-03-14 | 2021-11-19 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Spain | Acceptable with conditions 2024-08-26
|
2024-08-26 |