Off-the-shelf BCMA CAR‑T for relapsed or refractory multiple myeloma
Official title: A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r/r Multiple Myeloma
Run by Bioray Laboratories · NCT07248176 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 6 (estimated) |
| Sponsor | Bioray Laboratories Industry-sponsored |
| Drugs / interventions | CAR-T, immunotherapy |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | April 10, 2025 |
| Main results expected | March 15, 2027 |
| Study ends | April 18, 2028 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07248176 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Shanghi Tongji Hospital (Tongji Hospital of Tongji University)
Shanghai, China Recruiting
Study contacts
- Study coordinator: Ping Li, phD
- Email: lilyforever76@126.com
- Phone: 13564181131
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
NT-I7 added to BCMA CAR-T therapy for relapsed or refractory multiple myeloma
This trial tests whether giving NT-I7 after BCMA CAR-T therapy helps boost T-cell expansion and possibly improve responses in people with relapsed or refractory multiple myeloma.
-
Sequential CAR-T therapy targeting BCMA and GPRC5D for relapsed or refractory multiple myeloma
This will try sequential CAR-T cell therapy against BCMA and GPRC5D in people with relapsed or refractory multiple myeloma to see if it is safe and helps control the disease.
-
In Vivo BCMA-CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
This study tests VV169, a one-time in vivo CAR-T treatment, in adults with multiple myeloma that has come back or not responded to standard therapy.
-
CAR-T therapy for relapsed or refractory multiple myeloma
This study tests a CAR-T therapy in people with multiple myeloma whose disease has come back or not responded to treatment.
-
Elranatamab given as outpatient in relapsed or refractory multiple myeloma
This study tests a bispecific antibody called elranatamab, given in an outpatient setting to adults with relapsed or refractory multiple myeloma who have had prior therapies.
-
Early palliative care for patients with multiple myeloma and aggressive lymphoma
This study is testing if early palliative care can improve the quality of life and comfort for people with multiple myeloma and aggressive lymphoma while they receive their usual cancer treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.