lifileucel
Trade name: Amtagvi
Cell therapyapprovedOrphan Drug FDA
Approved
Feb 16, 2024
Clinical trial activity
11 trials · 7 clinical orgs · 1 marketing orgs
Phase 1
5
Phase 2
5
Phase 3
1
Phase 4
0
Earliest trial started Oct 31, 2018 (NCT03645928)
Timeline
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Somatic cell supplemental therapy
Tumor-derived autologous T cell immunotherapy composed primarily of T cells of the CD4+T and CD8+T cell lineages.
- Tumor antigensImmunity, passive
immunity, passive - tumor antigens
Approval history
- approvedAcceleratedFeb 16, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL4298200 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07288203 | Phase 2 | Nov 28, 2025 | Iovance |
| NCT06190249 | Phase 1 | Dec 31, 2024 | Case Western Reserve University, Iovance |
| NCT06743126 | Phase 3 | Dec 31, 2024 | immatics Biotechnologies GmbH |
| NCT06481592 | Phase 2 | Oct 31, 2024 | Iovance |
| NCT06566092 | Phase 1 | Mar 28, 2024 | Iovance |
| NCT06151847 | Phase 2 | Jan 27, 2024 | Iovance, National Cancer Institute (NCI), University of Kansas |
| NCT05640193 | Phase 1 | Nov 25, 2022 | Iovance, Memorial Sloan-Kettering Cancer Center |
| NCT05607095 | Phase 1 | Nov 1, 2022 | Iovance, Memorial Sloan-Kettering Cancer Center |
| NCT05176470 | Phase 1 | Jul 1, 2022 | Iovance, Ohio State University |
| NCT03645928 | Phase 2 | Oct 31, 2018 | Iovance |
| NCT05398640 | N/A | — | Iovance |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Iovance | For profit | 10 | 5 | 3 | 2018 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 2 | 1 | 2022 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| immatics Biotechnologies GmbH | For profit | 1 | 1 | 1 | 2024 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2024 |
| Ohio State University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Kansas | Academic/Hospital | 1 | 1 | 1 | 2024 |
7 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Iovance | For profit | NDA | Feb 16, 2024 |