BL-M24D1 for multiple myeloma and other blood cancers that returned or did not respond

Trial details

Who runs it

Sichuan Baili Pharmaceutical Co., Ltd.

Trial code

NCT07255898

Record updated

4 June 2026

Original description

This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-M24D1 in patients with relapsed or refractory multiple myeloma and other hematologic malignancies.Read full original descriptionShow less

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M24D1 for Injection in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-M24D1 in patients with relapsed or refractory multiple myeloma and other hematologic malignancies.

Inclusion: Voluntarily sign the informed consent form and comply with the protocol requirements; Gender is not restricted; Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib); Expected survival time ≥3 months; Histologically and/or cytologically confirmed multiple myeloma or other hematologic malignancies that have failed standard treatment or for which no standard treatment currently exists; Must have measurable indicators as defined by the protocol; Physical condition score ECOG 0 or 1; Toxicity from previous antitumor treatments has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; Organ function levels must meet the requirements; Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN; 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: Use of chemotherapy, biologics, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives; Diagnosis of other malignancies within 5 years prior to the first dose; Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose; Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration, etc; Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration; Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first study drug administration; Participation in another clinical trial within 4 weeks prior to the first dose; Patients who received live vaccines within 30 days prior to the first dose; History of severe heart disease; Active autoimmune diseases and inflammatory diseases; Hypertension poorly controlled by two antihypertensive medications; Lung diseases defined as ≥ Grade 3 according to CTCAE v5.0; history of interstitial lung disease requiring hormone treatment, etc; Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M24D1; Human immunodeficiency virus antibody positivity, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; Other conditions deemed by the investigator as unsuitable for participation in this clinical trial; QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block; Patients with poorly controlled blood glucose; Subjects with central nervous system involvement, etc; Patients with peripheral neuropathy ≥ Grade 3 or persistent ≥ Grade 2 peripheral neuropathy with pain; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT07255898