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A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT05924750 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-09-26

No results posted yet for this study

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

  • Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Interventions

DRUG

BL-M11D1

Administration by intravenous infusion

Sponsors & Collaborators

  • Sichuan Baili Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junyuan Qi, PHD · Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

  • Jianxiang Wang, MS · Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05924750 on ClinicalTrials.gov