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Cilta-cel and Talquetamab in High-Risk Multiple Myeloma
NCT06550895Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2024
- Primary completion
- Aug 2027
- Countries
- 2
- Sponsor
- Janssen Pharmaceutical
- Modality
- Gene Editing, Gene Silencing, CAR-T Cells
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, open-label, single-arm trial of ciltacabtagene autoleucel and talquetamab in multiple myeloma (MM), sponsored by Janssen Pharmaceutical. Primary endpoint: Number of Participants With Adverse Events (AE) by Severity. Started Sep 2024; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy
Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment
03
Who it enrols
Participants must have relapsed/refractory multiple myeloma with at least 3 prior lines of therapy, ECOG 0-1, and no prior CAR-T, BCMA-directed, or GPRC5D-directed therapies.
04
Endpoints
Primary
Number of Participants With Adverse Events (AE) by Severity
Secondary
Percentage of Participants With Overall Response (OR)
Percentage of Participants with Very Good Partial Response (VGPR) or Better
Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR)
Duration of Response
Time to Response
Progression Free Survival
Overall Survival
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