What is BL-M24D1 studying for multiple myeloma and other blood cancers?

BL-M24D1 is being studied to understand its safety, how it is processed in the body, and its early effects in patients with relapsed or refractory multiple myeloma and other hematologic malignancies. The research aims to find out if this drug could be a treatment option for patients who have limited alternatives. Sichuan Baili Pharmaceutical Co., Ltd. is leading this clinical trial.

Who may be eligible for this multiple myeloma clinical trial?

Adults aged 18 and older with relapsed or refractory multiple myeloma or other blood cancers may be eligible. Participants should have a good physical condition score and no severe heart disease or active infections. Both men and women can join, but women of childbearing potential must have a negative pregnancy test and use contraception. Please review eligibility criteria for more details.

Is there any cost to participate in this multiple myeloma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID07255898

Phase I Study of BL-M24D1 Intravenous Treatment in Adults With Relapsed or Refractory Multiple Myeloma and Other Blood Cancers

Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-06-04

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

Sa Xiao, PHD

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Phase I Study of BL-M24D1 Intravenous Treatment in Adults With Relapsed or Refractory Multiple Myeloma and Other Blood Cancers

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria