Clinical trial · Interventional
Study of BCMA CAR-T in Multiple Myeloma
A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma
NCT03322735CI-TRIAL-00030972unknownPhase 1 / Phase 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)
The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA CAR-T | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-tumor response of BCMA CAR-T
- description
- Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days. Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.
- interventionNames
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Biological: BCMA CAR-T
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- 1 year
- description
- number of participants with adverse events
Secondary outcomes (2)
- measure
- Persistence of the BCMA CAR+ T cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. 18 years to 70 years, expected survival \> 3 months; * 2\. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry. * 3\. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.； * 4\. ECOG performance status of 0-2; * 5\. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; * 6\. No serious allergic constitution; * 7\. No other serous diseases that conflicts with the clinical program; * 8\. No other cancer history; * 9\. female participants of reproductive potential must have a negative serum pregnancy test; * 10\. Subjects must have signed written, informed consent. Exclusion Criteria: * 1\. Pregnant or lactating women; * 2\. Uncontrolled active infection, HIV infection, syphilis serology reaction positive; * 3\. Active hepatitis B or hepatitis C infection; * 4\. Recent or current use of glucocorticoid or other immunosuppressor; * 5\. serious mental disorder; * 6\. With severe cardiac, liver, renal insufficiency, diabetes and other diseases; * 7\. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
References
Publications (0)
Data not yet available
No reference posted for this study.