Clinical trial · Interventional
Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma
Safety and Efficacy Evaluation of Autologous BCMA-CART for Treating Relapsed or Refractory Multiple Myeloma
NCT03492268CI-TRIAL-00058518withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to CART processing facility construction
Summary
Brief summary (as posted)
This trial aims to evaluate the safety and efficacy of BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA-CART | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCMA-CART
- description
- Autologous T cells transduced to express anti-BCMA chimeric antigen receptor (CAR)
- interventionNames
- Biological: BCMA-CART
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 90 days after T cell infusion
- description
- Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.
Secondary outcomes (2)
- measure
- Incidence and Severity of Adverse Events as a Measure of Safety
- timeFrame
- Baseline up to 35 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Have the capacity to give informed consent; * Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria; * Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment); * Refractory and relapsed MM patients after \> 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT); * ECOG score=0-2. Exclusion Criteria: * Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy; * Active infection, HIV infection, syphilis serology reaction positive; * Active hepatitis B, hepatitis C at the time of screening; * Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)\> 5 x upper limit of normal; bilirubin \> 3.0 mg/dL; * Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis serious mental disorder; * With severe cardiac, liver, renal insufficiency, diabetes and other diseases; * Participate in other clinical research in the past three months; previously treatment with any gene therapy products; * Contraindication to cyclophosphamide or fludarabine chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.