Overview
Sponsor-declared trial summary
Relapsed or refractory (R/R) Acute lymphoblastic leukemia (ALL), R/R Acute myeloid leukemia (AML), R/R Acute mixed-phenotype leukemia (AMPL), R/R Diffuse large B-cell lymphoma (DLBCL), R/R Chronic lymphocytic leukemia (CLL), R/R Small lymphocytic lymphoma (SLL)
Key facts
- Sponsor
- Biomea Fusion Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Feb 2023 → 6 Mar 2025
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515744-23-00
- EudraCT number
- 2022-002798-27
- ClinicalTrials.gov
- NCT05153330
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or refractory (R/R) Acute lymphoblastic leukemia (ALL), R/R Acute myeloid leukemia (AML), R/R Acute mixed-phenotype leukemia (AMPL), R/R Diffuse large B-cell lymphoma (DLBCL), R/R Chronic lymphocytic leukemia (CLL), R/R Small lymphocytic lymphoma (SLL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086466 | Relapsed/refractory multiple myeloma | 100000004848 |
| 21.1 | LLT | 10008978 | Chronic lymphocytic leukemia refractory | 10029104 |
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
| 21.0 | PT | 10012822 | Diffuse large B-cell lymphoma refractory | 100000004864 |
| 21.0 | LLT | 10000835 | Acute leukemia | 10029104 |
| 21.1 | PT | 10003912 | B-cell small lymphocytic lymphoma refractory | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biomea Fusion Inc.
- Sponsor organisation
- Biomea Fusion Inc.
- Address
- 900 Middlefield Road Floor 4
- City
- Redwood City
- Postcode
- 94063-1681
- Country
- United States
Scientific contact point
- Organisation
- Biomea Fusion Inc.
- Contact name
- Biomea Fusion, Inc. Clinical Operations
Public contact point
- Organisation
- Biomea Fusion Inc.
- Contact name
- Biomea Fusion, Inc. Clinical Operations
Locations
2 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 4 |
| Spain | Ended | 18 | 10 |
| Rest of world
United States
|
— | 144 | — |
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-05-15 | 2023-06-19 | 2025-01-15 | ||
| Spain | 2023-02-15 | 2023-04-20 | 2025-01-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-17 | Spain | Acceptable 2024-10-08
|
2024-10-08 |