Clinical trial · Interventional
BCMA-CS1 Compound CAR (cCAR) T Cells for Relapsed/Refractory Multiple Myeloma
Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of BCMA-CS1 cCAR in Patients With Relapsed and/or Refractory Multiple Myeloma
NCT04156269CI-TRIAL-00041578unknownEarly Phase 1ClinicalTrials.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)
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CS1 cCAR in patients with relapsed and/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-CS1 cCAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCMA-CD33 cCAR T cells
- description
- BCMA-CS1 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-BCMA and CS1 CARs
- interventionNames
- Biological: BCMA-CS1 cCAR T cells
Primary outcomes (3)
- measure
- Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- timeFrame
- 28 days
- measure
- Type of dose-limiting toxicity (DLT)
- timeFrame
- 28 days
- measure
- Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis based on the World Health Organization (WHO) 2008 2. Patients have exhausted standard therapeutic options 3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks 4. Female must be not pregnant during the study Exclusion Criteria: 1. Prior solid organ transplantation 2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant 3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
References
Publications (0)
Data not yet available
No reference posted for this study.