Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
80
Countries
1
Sites
4
Relapsed/Refractory AML or Higher-Risk MDS
Key facts
- Sponsor
- Remix Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 5 Aug 2025 → ongoing
- Decision date (initial)
- 2024-07-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory AML or Higher-Risk MDS
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10068361 | MDS | 10029104 |
| 20.0 | LLT | 10066572 | AML progression | 10029104 |
| 20.0 | LLT | 10001941 | AML | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Remix Therapeutics Inc.
- Sponsor organisation
- Remix Therapeutics Inc.
- Address
- 100 Forge Road Suite 400
- City
- Watertown
- Postcode
- 02472-2265
- Country
- United States
Scientific contact point
- Organisation
- Remix Therapeutics Inc.
- Contact name
- Jennifer Webster
Public contact point
- Organisation
- Remix Therapeutics Inc.
- Contact name
- Jennifer Webster
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 20 | 4 |
| Rest of world
United States
|
— | 60 | — |
Investigational sites
Institut Gustave Roussy
Hématologie, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Hématologie Clinique et Thérapie Cellulaire, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Paris
Hématologie - Immunologie, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncologie médicale - Unité de phases précoces, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
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 | 2024-11-24 | 2024-12-04 | 2025-04-02 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-78735
- Halt date
- 2025-04-02
- Member states concerned
- France
- Publication date
- 2025-04-10
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- As per REM-422-102 Study Stopping Rules (Section 11.1.1):
In the event of a participant death assessed as possibly related to REM-422, enrollment in the study will be paused and the DRC will examine the entirety of available data, encompassing safety, PK, Pd, and preliminary antitumor activity. The objective is to make a well-informed recommendation regarding whether to resume enrollment in the study or not. - Follow-up measures
- Please check further details on attached notification letters.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-27 | France | Acceptable with conditions 2024-07-01
|
2024-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-10 | France | Acceptable 2024-09-23
|
2024-09-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-17 | France | Acceptable 2025-02-25
|
2025-02-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-31 | France | Acceptable 2025-05-14
|
2025-05-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-28 | France | Acceptable with conditions 2025-08-04
|
2025-08-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-13 | France | Acceptable 2025-09-05
|
2025-09-15 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-26 | France | Acceptable 2025-09-05
|
2025-11-26 |