Afamitresgene autoleucel - Adaptimmune
Alternative Names: ADP A2M4; afami-cel - adaptimmune; MAGE-A4 SPEAR T-cell therapy; MAGE-A4 TCR; MAGE-A4-SPEAR-T-cell-therapy-Adaptimmune; MAGE-A4c1032T; MAGE-A4ᶜ¹º³²T; Melanoma-associated antigen A4-specific T-cells - Adaptimmune; TECELRALatest Information Update: 04 Oct 2024
At a glance
- Originator Adaptimmune
- Class Antineoplastics; Gene therapies; Immunotherapies; T lymphocyte cell therapies
- Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Registered Synovial sarcoma
- Phase II Myxoid liposarcoma
- Phase I/II Neuroblastoma; Neurofibrosarcoma; Osteosarcoma
Most Recent Events
- 27 Sep 2024 Adaptimmune initiates an expanded-access programme for Synovial Sarcoma and Myxoid liposarcoma in USA (IV, Infusion) (NCT06617572)
- 13 Aug 2024 Adaptimmune temporarily suspends enrollment in a phase-I/II clinical trials in Synovial sarcoma, Osteosarcoma, Neurofibrosarcoma, Neuroblastoma (In adolescents, In children, Late-stage disease, Second-line therapy or greater, In adults) in USA (IV) (NCT05642455) (Adaptimmune pipeline, August 2024)
- 02 Aug 2024 Registered for Synovial sarcoma (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (IV) - First Global Approval (Accelerated approval)