Clinical trial · Interventional
Efficacy and Safety Evaluation of BCMA-UCART
Efficacy and Safety Evaluation of BCMA-UCART(Allogeneic Engineered T-cells Expressing Anti-BCMA Chimeric Antigen Receptor)in the Treatment of Relapsed or Refractory Multiple Myeloma
NCT03752541CI-TRIAL-00058621suspendedN/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): decided by the sponsor
Summary
Brief summary (as posted)
This trial aims to evaluate the safety and efficacy of BCMA-UCART 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-UCART | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCMA-UCART
- description
- Each subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1\*10\~6/KgBW, 1-2\*10\~6/KgBW,2-3\*10\~6/KgBW.
- interventionNames
- Biological: BCMA-UCART
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 and Tolerability
- timeFrame
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. * Subjects according with any of the following options: * Age≥50; * Failure with separation of T cells during autologous CART processing; or, * Failure with expansion of autologous CART; or, * The proportion of T cells in PBMC \<10%; or, * Won't benefit from autologous CART therapy because of disease progress. 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.