Trials / Recruiting
RecruitingNCT05924750
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of BL-M11D1. Ib: Further observe the safety and tolerability of BL-M11D1 at the recommended dose in phase Ia to determine the recommended dose in phase II clinical study (RP2D).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BL-M11D1 | Administration by intravenous infusion |
Timeline
- Start date
- 2023-08-02
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2023-06-29
- Last updated
- 2025-09-26
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05924750. Inclusion in this directory is not an endorsement.