Off-the-shelf BCMA CAR‑T for relapsed or refractory multiple myeloma

A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r/r Multiple Myeloma

This trial will try a universal (allogeneic) BCMA-directed CAR‑T cell treatment for people with relapsed or refractory multiple myeloma to see if it is safe and can reduce disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bioray Laboratories (Industry-sponsored)
• Drugs / interventions: CAR-T, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT07248176 on ClinicalTrials.gov

What this trial studies

This is a non-randomized, open-label, single-arm trial testing BCMA-targeted allogeneic (universal) CAR‑T cells in patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy. Participants must be BCMA positive with ECOG 0–1 and adequate organ function. The study administers targeted gene‑modified allogeneic CAR‑T cell infusions and follows patients for safety and measures of anti-myeloma activity. Key outcomes include adverse events, response rates by IMWG criteria, and durability of response.

Who should consider this trial

Good fit: Ideal candidates are adults with BCMA-positive relapsed or refractory multiple myeloma after at least two prior anti-myeloma therapies, an ECOG score of 0–1, expected survival of ≥3 months, and no severe organ dysfunction.

Not a fit: Patients who previously received allogeneic stem cell transplant, prior CAR‑T or other genetically modified T‑cell therapies, prior BCMA-targeted therapy, those with active infection, significant CNS disease, severe cardiovascular disease, positive virology, pregnancy, or active autoimmune disease are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, this off-the-shelf BCMA CAR‑T approach could provide faster access to potent cellular therapy and potentially induce meaningful remissions in patients who have exhausted other treatments.

How similar studies have performed: Autologous BCMA-directed CAR‑T therapies have produced high response rates in relapsed/refractory myeloma, while allogeneic (universal) BCMA CAR‑T approaches are promising but remain earlier in development with less mature efficacy and safety data.

Eligibility criteria

Inclusion Criteria:

1. Expected survival of at least 3 months;
2. Subjects should have measurable disease that meets the IMWG 2016 criteria;
3. Previously received at least two lines of prior anti-myeloma therapy ；
4. Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ；
5. BCMA positive；
6. ECOG score 0-1；
7. No severe impairment or suppression of liver, kidney, coagulation, bone marrow, or lung function.

Exclusion Criteria:

1. Pregnant or breastfeeding women;
2. History of other malignant tumors;
3. Active autoimmune diseases requiring immunotherapy;
4. Previously received allogeneic stem cell transplantation;
5. Previous use of CAR-T cells or other genetically modified T cell therapies;
6. Previously received targeted BCMA therapy;
7. Severe cardiovascular disease;
8. Active infection;
9. Positive virology test;
10. Clinically significant central nervous system (CNS) diseases or pathological changes.

Where this trial is running

Shanghai

• Shanghi Tongji Hospital (Tongji Hospital of Tongji University) — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Ping Li, phD

Conditions Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma, Refractory