idecabtagene vicleucel
Trade name: Abecma
Small moleculeapprovedOrphan Drug FDA
Approved
Mar 3, 2021
B-cell maturation antigen, also known as tumor necrosis factor receptor superfamily member 17 (TNFRSF17), is a protein that in humans is encoded by the TNFRSF17 gene. — Wikipedia
Clinical trial activity
10 trials · 10 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
8
Phase 3
2
Phase 4
0
Earliest trial started Jan 1, 2016 (NCT02658929)
Timeline
2010s
2020s
- Mar 3, 2021
Bristol-Myers Squibb — Earliest FDA Approval
- Mar 3, 2021
Bristol-Myers Squibb — NDA Secondary Org
- Mar 3, 2021
Bristol-Myers Squibb — NDA Organization
Indications
Approved for
Mechanism of action
- BCMABINDING AGENT
BCMA binding agent
- Tumor necrosis factor receptor superfamily member 17BINDING AGENT
Tumor necrosis factor receptor superfamily member 17 binding agent
T cell immunotherapy product (CAR-T)
Approval history
- approvedMar 3, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Black box warning
Sources
- WikipediaB-cell maturation antigen ↗
- ChEMBLCHEMBL4298199 ↗
Also known as
- bb2121
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06045806 | Phase 3 | Oct 16, 2023 | Bristol-Myers Squibb, Celgene |
| NCT05393804 | Phase 2 | May 20, 2022 | Memorial Sloan-Kettering Cancer Center |
| NCT05032820 | Phase 2 | Oct 31, 2021 | Blood and Marrow Transplant Clinical Trials Network, Bristol-Myers Squibb, Medical College of Wisconsin, Memorial Sloan-Kettering Cancer Center, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Marrow Donor Program |
| NCT04855136 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2021 | Celgene |
| NCT03642626 | Phase 2 | Dec 18, 2018 | University of Minnesota |
| NCT03651128 | Phase 3 | Oct 12, 2018 | Celgene |
| NCT03601078 | Phase 2 | Oct 12, 2018 | Celgene |
| NCT03361748 | Phase 2 | Dec 13, 2017 | Celgene |
| NCT02658929 | Phase 1 | Jan 1, 2016 | bluebird bio |
| NCT04771078 | N/A | — | Bristol-Myers Squibb, Celgene |
Showing 10 of 10 trials
Page 1 / 1
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Celgene | For profit | 6 | 6 | 3 | 2017 |
| Bristol-Myers Squibb | For profit | 3 | 0 | 3 | 2021 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 1 | 1 | 2021 |
| Blood and Marrow Transplant Clinical Trials Network | Academic/Hospital | 1 | 0 | 1 | 2021 |
| bluebird bio | For profit | 1 | 1 | 1 | 2016 |
| Medical College of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2021 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2021 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 1 | 0 | 1 | 2021 |
| National Marrow Donor Program | Government | 1 | 0 | 1 | 2021 |
| University of Minnesota | Academic/Hospital | 1 | 1 | 1 | 2018 |
10 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bristol-Myers Squibb | For profit | NDA2 | Mar 3, 2021 |
| Bristol-Myers Squibb | For profit | NDA | Mar 3, 2021 |