Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
97
Countries
2
Sites
6
Relapsed/Refractory Multiple Myeloma (RRMM)
Key facts
- Sponsor
- Harpoon Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Oct 2020 → 8 Apr 2026
- Decision date (initial)
- 2024-09-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515582-33-00
- EudraCT number
- 2019-004793-26
- WHO UTN
- U1111-1261-6031
- ClinicalTrials.gov
- NCT04184050
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory Multiple Myeloma (RRMM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Harpoon Therapeutics Inc.
- Sponsor organisation
- Harpoon Therapeutics Inc.
- Address
- 611 Gateway Boulevard Suite 400
- City
- South San Francisco
- Postcode
- 94080-7066
- Country
- United States
Scientific contact point
- Organisation
- Harpoon Therapeutics Inc.
- Contact name
- Senior Scientist
Public contact point
- Organisation
- Harpoon Therapeutics Inc.
- Contact name
- Associate Director
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 5 | 2 |
| Spain | Ended | 5 | 4 |
| Rest of world
United States
|
— | 87 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
hematology and cellular therapy, 2 Rue De La Miletrie, 86000, Poitiers
CHU Nantes
Hematology, 1 Place Alexis Ricordeau, 44093, Nantes
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario De Navarra
Hematology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Institut Catala d'oncologia Hospital Universitari Germans Trias i Pujol
Medical Hematology, Ganduxer 117, 08022, Barcelona
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 | 2021-03-11 | 2026-03-12 | 2021-04-13 | 2023-06-28 | |
| Spain | 2020-10-26 | 2026-04-08 | 2021-09-08 | 2024-03-12 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-09 | Spain | Acceptable with conditions 2024-09-11
|
2024-09-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-07 | Spain | Acceptable 2025-05-23
|
2025-05-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-30 | Acceptable 2025-05-23
|
2025-07-30 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-02 | Spain | Acceptable 2025-05-23
|
2025-11-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-17 | Spain | Acceptable 2026-02-16
|
2026-02-16 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-24 | Spain | Acceptable 2026-02-16
|
2026-04-24 |