Actively Recruiting
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
130
Participants Needed
8
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and agree to follow the study protocol
- No gender restrictions
- Age between 18 and 75 years
- Expected survival time of 3 months or more
- Confirmed CD33-positive relapsed or refractory acute myeloid leukemia
- Bone marrow blast count of 5% or higher
- ECOG performance status score of 2 or less
- Peripheral blood white blood cell count of 25 x 10^9/L or less before the first dose
- Toxicity from previous anti-tumor treatments recovered to Grade 1 or less
- Organ functions within required levels within 7 days before first dose
- Negative pregnancy test within 7 days before treatment for premenopausal women with childbearing potential
- Not breastfeeding for premenopausal women with childbearing potential
- Use adequate contraception during treatment and for 6 months after treatment ends
You will not qualify if you...
- Acute promyelocytic leukemia or acute transformation of chronic myeloid leukemia
- Antineoplastic therapy (chemotherapy, biologic therapy, immunotherapy, radiotherapy, major surgery, targeted therapy) within 4 weeks or 5 half-lives before first dose
- Palliative radiotherapy within 2 weeks before first dose
- Severe heart disease including left ventricular ejection fraction below 50%, symptomatic congestive heart failure grade 2 or higher, NYHA grade 2 or higher heart failure, history of myocardial infarction, or unstable angina
- Prolonged QT interval or serious heart conduction problems
- Active autoimmune or inflammatory diseases requiring systemic treatment, excluding type I diabetes, controlled hypothyroidism, or mild skin diseases
- Other cancers diagnosed within 5 years, except some skin cancers
- Poorly controlled high blood pressure
- Severe pulmonary disease or interstitial lung disease
- Central nervous system involvement
- Allergy to recombinant humanized or human-mouse chimeric antibodies or ingredients of BL-M11D1
- Prior organ transplant or allogeneic hematopoietic stem cell transplant
- HIV positive, active tuberculosis, or active hepatitis B or C infection
- Active infection needing systemic treatment
- Significant effusions requiring drainage
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Not Yet Recruiting
2
Beijing Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
Institute of Hematology, the First Hospital of Harbin
Haerbin, Heilongjiang, China
Not Yet Recruiting
4
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
5
Qilu Hospital of Shandong University
Jinan, Shangdong, China
Not Yet Recruiting
6
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
7
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
8
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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