Afamitresgene autoleucel
Cell therapyapprovedOrphan Drug FDA
Approved
Aug 1, 2024
Clinical trial activity
7 trials · 5 clinical orgs · 0 marketing orgs
Phase 1
2
Phase 2
5
Phase 3
0
Phase 4
0
Earliest trial started Aug 1, 2019 (NCT04044768)
Timeline
Indications
Approved for
Studied for
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Carcinoma, Transitional Cell · Phase 1
- Endometrial Neoplasms · Phase 1
- Esophageal Diseases · Phase 1
- Esophageal Neoplasms · Phase 2
- Esophagogastric Junction · Phase 1
- Head and Neck Neoplasms · Phase 2
- Liposarcoma, Myxoid · Phase 2
- Melanoma · Phase 1
- Nerve Sheath Neoplasms · Phase 1/Phase 2
- Neuroblastoma · Phase 1/Phase 2
- Osteosarcoma · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 2
- Sarcoma, Synovial · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 1
- Stomach Neoplasms · Phase 1
Mechanism of action
- Melanoma-associated antigen 4BINDING AGENT
Melanoma-associated antigen 4 binding agent
T cell immunotherapy product consisting of genetically modified autologous CD4 and CD8 positive T cells.
- Melanoma-associated antigen 3Immunity, passive
MAGEA3 immunity, passive
Approval history
- approvedAcceleratedAug 1, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL4802254 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05642455 | Phase 1/Phase 2 (Phase 2) | May 1, 2023 | Adaptimmune, Memorial Sloan-Kettering Cancer Center |
| NCT05601752 | Phase 2 | Dec 4, 2022 | Adaptimmune, GOG Foundation, Inc. |
| NCT04752358 | Phase 2 | Sep 15, 2021 | Adaptimmune, ICON |
| NCT04408898 | Phase 2 | Jun 30, 2020 | Adaptimmune |
| NCT04044859 | Phase 1 | Sep 30, 2019 | Adaptimmune |
| NCT04044768 | Phase 2 | Aug 1, 2019 | Adaptimmune, University of Texas at Houston |
| NCT06617572 | N/A | — | Adaptimmune |
Showing 7 of 7 trials
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Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Adaptimmune | For profit | 7 | 7 | 3 | 2019 |
| GOG Foundation, Inc. | Academic/Hospital | 1 | 0 | 1 | 2022 |
| ICON | For profit | 1 | 0 | 1 | 2021 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 1 | 0 | 1 | 2023 |
| University of Texas at Houston | Academic/Hospital | 1 | 0 | 1 | 2019 |
5 organizations
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