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A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05924750•Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign the informed consent form and comply with the protocol requirements;
•2. No gender restrictions;
•3. Age: ≥18 years and ≤75 years;
•4. Expected survival time ≥3 months;
•5. Histologically and/or cytologically confirmed CD33-positive relapsed/refractory acute myeloid leukemia (AML);
•6. Morphological assessment showing ≥5% blasts in the bone marrow;
•7. ECOG performance status score ≤2;
•8. Peripheral blood white blood cell count ≤25×10\^9/L before the first dose;
•9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
•10. Organ function levels meet the requirements within 7 days before the first dose;
+1 more criteria

Exclusion Criteria

•1. Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia.
•2. Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors), has been administered within 4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; Or palliative radiotherapy within 2 weeks before the first dose.
•3. History of severe heart disease, such as left ventricular ejection fraction \< 50%, history of symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of myocardial infarction, unstable angina, etc.
•4. Prolonged QT interval (QTc \> 450 msec in men or QTc \> 470 msec in women), complete left bundle branch block, and III degree atrioventricular block.
•5. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory intestinal diseases and Hashimoto's thyroiditis, etc., excluding type I diabetes mellitus, hypothyroidism that can only be controlled by replacement therapy, and skin diseases without systemic treatment (such as vitiligo and psoriasis).
•6. Other malignancies diagnosed within 5 years before the first dose, except for radical basal cell carcinoma, squamous cell carcinoma, and/or radical resection carcinoma in situ.
•7. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg).
•8. Patients with pulmonary disease grade ≥3 defined by CTCAE v5.0, current or previous interstitial lung disease (ILD).
•9. Patients with central nervous system involvement.
•10. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M11D1.
+7 more criteria

Locations (8)

Anhui Provincial Hospital

Hefei, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Institute of Hematology, the First Hospital of Harbin

Haerbin, Heilongjiang, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shangdong, China

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

August 2, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

September 26, 2025

Enrollment

130

ESTIMATED participants

Conditions

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

Interventions

BL-M11D1

DRUG

Contacts

Sa Xiao, PHD

CONTACT

+8615013238943 xiaosa@baili-pharm.com