What is BCMA-CART studying for multiple myeloma?

BCMA-CART is being studied to evaluate its safety and effectiveness in treating young patients with newly diagnosed multiple myeloma. This clinical trial compares BCMA-CART treatment alone or combined with autologous stem cell transplant (ASCT) to understand the best approach. The study is conducted by the Institute of Hematology & Blood Diseases Hospital in China.

Who may be eligible for this multiple myeloma clinical trial?

Adults aged 18 to 50 years with a confirmed diagnosis of multiple myeloma may be eligible. Participants should have adequate organ function and no severe heart disease or uncontrolled infections. Both females and males can join, with women of childbearing potential required to 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 or procedure and all trial visits, is provided at no cost. However, personal travel or other expenses are not guaranteed to be covered and may vary. Participants should plan accordingly for any costs related to attending the study visits.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 50Years

All Genders

ID07169500

Clinical Study on the Safety and Efficacy of BCMA-CART with or without Autologous Stem Cell Transplant in Treating Young Multiple Myeloma Patients

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of BCMA-CART treatment with or without autologous stem cell transplant ASCT in young patients newly diagnosed with multiple myeloma. This prospective, open-label study divides participants into transplant and non-transplant groups based on their medical condition to compare these treatment approaches. The study focuses on young adults with multiple myeloma to assess differences in outcomes between those receiving ASCT alongside BCMA-CART and those receiving BCMA-CART alone. Participants suitable for transplant will receive ASCT before undergoing BCMA-CART therapy, while those not suitable for transplant will proceed directly to BCMA-CART treatment. The treatment assignment is non-randomized and based on disease status before starting therapy. BCMA-CART involves genetically engineered immune cells designed to target the cancer, and the study aims to analyze the safety and efficacy of these treatment methods in young multiple myeloma patients. During the study, researchers will assess minimal residual disease MRD negativity rates three months after treatment and monitor progression-free survival, overall response, duration and timing of response, overall survival, and pharmacokinetics over two years following CAR-T infusion. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment effects. The total study period includes follow-up assessments up to two years to comprehensively evaluate outcomes and treatment impact.

CONDITIONS

Brief Title

Clinical Study on the Safety and Efficacy of BCMA-CART±ASCT in Treating Young Multiple Myeloma Patients

Who Can Participate

Age: 18Years - 50Years

All Genders

Eligibility Criteria

You may qualify if you...

Female, 18 to 55 years old
Voluntary participation with signed informed consent
Confirmed multiple myeloma diagnosis by flow cytometry or immunohistochemistry
Adequate organ function with specific laboratory values: total bilirubin ≤1.5x ULN, ALT and AST ≤2.5x ULN, creatinine clearance ≥40 ml/min, coagulation tests within set limits, hemoglobin ≥60 g/L, ANC ≥1.0 x 10^9/L, ALC ≥0.5 x 10^9/L, platelets ≥50 x 10^9/L, LVEF ≥45%, blood oxygen saturation ≥92%
ECOG performance status of 0-1
Expected survival of at least 3 months
Female participants of childbearing potential must have negative pregnancy test and not be breastfeeding
Use of effective contraception for 24 months after cell infusion for males and females of childbearing potential

You will not qualify if you...

Allergy to any component of the cellular product
Severe heart disease including recent myocardial infarction, unstable angina, severe arrhythmia, severe cardiomyopathy, or congestive heart failure NYHA class III or IV
Stroke or seizure within 6 months prior to consent
Autoimmune diseases, immunodeficiency, or need for immunosuppressive therapy
Other malignancies within 3 years except certain treated in situ cancers without recurrence
Active uncontrolled infection
Unstable systemic diseases including severe liver, kidney, or metabolic conditions
Positive tests for HBV DNA, HCV antibody and RNA, HIV antibody, syphilis, or CMV DNA within one week before lymphocyte collection
Use of prednisone over 5 mg/day or equivalent corticosteroids within one week before lymphocyte collection
Prior CAR-T or genetically modified T cell therapies
Prior BCMA-targeted therapy
Vaccination with live vaccine within 4 weeks before consent
History of alcoholism, drug abuse, psychiatric disorders, or other conditions deemed unsuitable by investigator

Research Team

Yan Xu, MD

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