Study design & results
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Trial intelligence / Profile preview
Long-term follow-up after gene-modified T-cell therapy
2023-504201-36-00Phase 3Authorised
- Sponsor
- Celgene Corporation
- Start
- Aug 2023
- Modality
- CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies, Vaccines & Immunotherapeutics
- Countries
- 22
01
Overview
Phase 3, open-label, single-arm trial of idecabtagene vicleucel, arilocacabtagene autoleucel, lisocabtagene maraleucel, BMS-986515, BMS-986453 and 4 more in hematopoietic malignancies, multiple myeloma (MM), B-cell malignancy and 2 more, sponsored by Celgene Corporation. Primary endpoints: Incidence of delayed adverse events related to gene-modified T-cell therapy, Persistence of gene-modified T cells and vector integration analysis (Cohort 1) and 3 more. Planned start Aug 2023; status: authorised.
02
Drugs
idecabtagene vicleucelarilocacabtagene autoleucellisocabtagene maraleucelBMS-986515BMS-986453
03
Conditions
hematopoietic malignanciesmultiple myeloma (MM)B-cell malignancydiffuse large B-cell lymphoma (DLBCL)Immune disorder
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