BL-M24D1 in relapsed or refractory multiple myeloma and other blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter, non-randomized Phase 1 study of BL-M24D1 in adults with relapsed or refractory multiple myeloma or other hematologic malignancies. The study uses a dose-escalation approach (Phase Ia) followed by an expansion cohort (Phase Ib) to characterize safety, tolerability, pharmacokinetics, and preliminary efficacy. Participants must have measurable disease, adequate organ function, and ECOG performance status of 0–1, and have exhausted standard therapies or have no available options. The trial is sponsored by Sichuan Baili Pharmaceutical and conducted at West China Hospital of Sichuan University in Chengdu, with collaboration from Baili-Bio, and aims to determine a safe dosing range and gather initial signals of activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Gender is not restricted;
3. Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
4. Expected survival time ≥3 months;
5. Histologically and/or cytologically confirmed multiple myeloma or other hematologic malignancies that have failed standard treatment or for which no standard treatment currently exists;
6. Must have measurable indicators as defined by the protocol;
7. Physical condition score ECOG 0 or 1;
8. Toxicity from previous antitumor treatments has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
9. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
10. Organ function levels must meet the requirements;
11. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
12. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, the serum pregnancy test must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should adopt adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Exclusion Criteria:

1. Subjects with central nervous system involvement, etc.;
2. Use of chemotherapy, biologics, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;
3. History of severe heart disease;
4. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block;
5. Active autoimmune diseases and inflammatory diseases;
6. Diagnosis of other malignancies within 5 years prior to the first dose;
7. Hypertension poorly controlled by two antihypertensive medications;
8. Patients with poorly controlled blood glucose;
9. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
10. Lung diseases defined as ≥ Grade 3 according to CTCAE v5.0; history of interstitial lung disease requiring hormone treatment, etc.;
11. Patients with peripheral neuropathy ≥ Grade 3 or persistent ≥ Grade 2 peripheral neuropathy with pain;
12. Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M24D1;
13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
14. Human immunodeficiency virus antibody positivity, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
15. Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration, etc.;
16. Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration;
17. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first study drug administration;
18. Participation in another clinical trial within 4 weeks prior to the first dose;
19. Pregnant or breastfeeding women;
20. Patients who received live vaccines within 30 days prior to the first dose;
21. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.