Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-M24D1 Injection in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-06-04
33
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of BL-M24D1 in patients with relapsed or refractory multiple myeloma and other blood cancers. This open, multicenter, non-randomized Phase I clinical trial aims to gather early data on how this investigational drug behaves and affects patients who have limited treatment options after standard therapies have failed or are unavailable. The study has two parts: a dose escalation phase (Phase Ia) and an expansion cohort phase (Phase Ib). Participants receive BL-M24D1 through intravenous infusion over a 2-week cycle. If clinical benefit is observed, patients may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons lead to stopping treatment. During the trial, participants undergo regular assessments including monitoring for dose-limiting toxicities within 28 days after the first dose and evaluation of the maximum tolerated dose. Over approximately 24 months, researchers will track treatment-emergent side effects, pharmacokinetic measures like drug concentration and clearance, immune responses to the drug, and clinical responses such as objective response rate and duration of response. The study includes safety follow-up and long-term monitoring.
CONDITIONS
Brief Title
A Study of BL-M24D1 in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow study rules
- Any gender
- Age 18 to 75 years for Phase Ia; 18 years and older for Phase Ib
- Expected survival of at least 3 months
- Confirmed diagnosis of multiple myeloma or other hematologic malignancies that failed standard treatment or have no standard treatment
- Measurable disease indicators as defined by the protocol
- Physical condition score ECOG 0 or 1
- Recovery from prior treatment toxicity to Grade 1 or less
- No severe heart dysfunction; left ventricular ejection fraction at least 50%
- Adequate organ function
- Coagulation tests within defined limits (INR ≤1.5, APTT ≤1.5 times upper limit)
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment and not breastfeeding
- Use adequate contraception during treatment and for 6 months after
You will not qualify if you...
- Involvement of the central nervous system
- Use of chemotherapy, biologics, or immunotherapy within 4 weeks before first dose or within 5 half-lives
- History of severe heart disease
- QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Other cancers diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two medications
- Poorly controlled blood glucose
- Unstable thrombotic events needing treatment within 6 months before first dose
- Severe lung disease (Grade 3 or higher) or history of interstitial lung disease needing hormone treatment
- Peripheral neuropathy Grade 3 or persistent Grade 2 with pain
- Allergy to recombinant humanized or chimeric antibodies or any BL-M24D1 components
- Previous organ or allogeneic stem cell transplant
- Positive HIV antibody or active tuberculosis or hepatitis B or C infection
- Active infection requiring treatment within 4 weeks before first dose
- Recent pleural, abdominal, pelvic, or pericardial effusion needing drainage or symptoms within 4 weeks
- Significant bleeding or bleeding tendency within 4 weeks before first dose
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or breastfeeding women
- Live vaccines within 30 days before first dose
- Other conditions judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each cycle lasts 2 weeks; additional cycles possible until disease progression or intolerable toxicity
Participants receive BL-M24D1 as an intravenous infusion for a cycle of 2 weeks. Those with clinical benefit may receive additional treatment cycles until disease progression, intolerable toxicity, or other reasons.
1 infusion visit per treatment cycle
Duration - Up to approximately 24 months
Participants are monitored for safety, tolerability, and treatment response after treatment ends, up to approximately 24 months.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
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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