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GEM-CAR-HiRiSMM: Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma
2023-510560-12-00Phase 2Authorised
- Sponsor
- PETHEMA
- Start
- Aug 2024
- Modality
- CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies
- Countries
- 1
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Overview
Phase 2, open-label, single-arm trial of ciltacabtagene autoleucel in multiple myeloma (MM), sponsored by PETHEMA. Primary endpoints: MRD negativity at 6 and 12 months and sustained MRD negativity, Safety: adverse events and serious adverse events and 1 more. Planned start Aug 2024; status: authorised.
02
Drugs
ciltacabtagene autoleucel
03
Conditions
multiple myeloma (MM)
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