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

NCT ID: NCT05924750

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2027-12-31

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study treatment

Participants receive BL-M11D1 as intravenous infusion for the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Group Type: EXPERIMENTAL

BL-M11D1

Intervention Type: DRUG

Administration by intravenous infusion

Interventions

BL-M11D1

Administration by intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

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;

11. For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.

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 &gt; 150 mmHg or diastolic blood pressure &gt; 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.

11. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).

12. Human immunodeficiency virus (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive; HBcAb positive and HBV-DNA copy number > lower detection limit) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower detection limit).

13. Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.

14. Presence of pleural, abdominal, pelvic or pericardial effusion with clinical symptoms or requiring repeated drainage.

15. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of last dose).

16. Pregnant or lactating women.

17. Other conditions for participation in the trial were not considered appropriate by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junyuan Qi, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Jianxiang Wang, MS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status: NOT_YET_RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Institute of Hematology, the First Hospital of Harbin

Haerbin, Heilongjiang, China

Site Status: NOT_YET_RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: NOT_YET_RECRUITING

Qilu Hospital of Shandong University

Jinan, Shangdong, China

Site Status: NOT_YET_RECRUITING

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Site Status: NOT_YET_RECRUITING

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

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

+8615013238943

Facility Contacts

Changcheng Zheng

Role: primary

Hui Liu

Role: primary

Tiejun Gong

Role: primary

Zhuogang Liu

Role: primary

Chunyan Ji

Role: primary

Ping Li

Role: primary

Yu Wu

Role: primary

Yali Zhang

Role: primary

ec@ihcams.ac.cn

022-23909095

Other Identifiers

BL-M11D1-101

Identifier Type: -

Identifier Source: org_study_id