NCT07255898 A Study of BL-M24D1 in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
| NCT ID | NCT07255898 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan Baili Pharmaceutical Co., Ltd. |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2026-03-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 33 participants in total. It began in 2026-03-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07255898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07255898 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07255898 currently recruiting?
Yes, NCT07255898 is actively recruiting participants. Contact the research team at xiaosa@baili-pharm.com for enrollment information.
Where is the NCT07255898 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07255898 clinical trial?
NCT07255898 is sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. The trial plans to enroll 33 participants.