Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
120
Countries
1
Sites
8
Urothelial cancer Esophageal cancer Gastric cancer Non-small cell lung carcinoma (NSCLC) Head and neck cancer carcinoma Ovarian carcinoma Melanoma Endometrial carcinoma
Key facts
- Sponsor
- Uswm Ct Llc
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 May 2020 → ongoing
- Decision date (initial)
- 2024-05-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512864-71-00
- EudraCT number
- 2019-001965-34
- ClinicalTrials.gov
- NCT04044859
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Urothelial cancer Esophageal cancer Gastric cancer Non-small cell lung carcinoma (NSCLC) Head and neck cancer carcinoma Ovarian carcinoma Melanoma Endometrial carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10029514 | Non-small cell lung cancer NOS | 10029104 |
| 24.1 | LLT | 10014743 | Endometrial carcinoma | 10029104 |
| 21.0 | LLT | 10017760 | Gastric cancer NOS | 10029104 |
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.0 | LLT | 10015362 | Esophageal cancer | 10029104 |
| 21.1 | LLT | 10077840 | Urothelial cancer of renal pelvis | 10029104 |
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uswm Ct Llc
- Sponsor organisation
- USWM Ct LLC
- Address
- 4441 Springdale Road
- City
- Louisville
- Postcode
- 40241-1086
- Country
- United States
Scientific contact point
- Organisation
- Adaptimmune LLC
- Contact name
- Regulatory Affairs
Public contact point
- Organisation
- Adaptimmune LLC
- Contact name
- Regulatory Affairs
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 32 | 8 |
| Rest of world
United Kingdom, United States, Canada
|
— | 88 | — |
Investigational sites
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
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 |
|---|---|---|---|---|---|
| Spain | 2020-05-27 | 2020-06-05 | 2024-09-12 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-08 | Spain | Acceptable 2024-05-23
|
2024-05-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-26 | Spain | Acceptable 2024-05-23
|
2025-02-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-18 | Spain | Acceptable 2024-05-23
|
2025-12-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-21 | Spain | Acceptable 2026-01-22
|
2026-01-22 |