Clinical trial · Interventional
Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
A Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor-modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
NCT06581640CI-TRIAL-00081031recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Relapsed/Refractory | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T treatment | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T
- interventionNames
- Biological: CAR-T treatment
Primary outcomes (1)
- measure
- Complete remission rate (CR)
- timeFrame
- Up to 36 months
- description
- Negative serum and urine immunofixation electrophoresis, disappearance of soft tissue plasmacytoma, and less than 5% plasma cells in the bone marrow. For patients who rely solely on serum FLC levels as a measurable lesion, in addition to meeting the above CR criteria, it is also required that the ratio of serum FLC is restored to normal in two consecutive evaluations.
Secondary outcomes (1)
- measure
- Adverse events (AE)
- timeFrame
- Up to 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-80 years, no gender restrictions; 2. Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies; 3. Flow cytometry or histology confirms positive BCMA expression in myeloma cells; 4. As judged by the investigator, the expected survival time is \>3 months; 5. ECOG performance status score ≤2, KPS \>60%; 6. The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin \<34 μmol/L; creatinine clearance rate \>30 mL/min; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%; 7. Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10\^9/L, PLT \>30×10\^9/L, Hb \>80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation; 8. Those with fertility must agree to use highly effective contraceptive methods; 9. The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily. Exclusion Criteria: 1. Pregnant or nursing women, as well as women planning to become pregnant within the next six months; 2. Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus; 3. History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity); 4. Previously received treatment targeting BCMA; 5. Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks; 6. Presence of uncontrolled active bacterial or fungal infection; 7. Allergic to research-related drugs or cell components; 8. Presence of active autoimmune diseases; 9. Currently have unstable or active ulcers or gastrointestinal bleeding; 10. Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders; 11. Received other experimental drug treatments within the last 3 months; 12. The researcher believes that for other reasons, the individual is not suitable for the clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.