Modality
Cell Therapy
MOA
USP1i
Target
CD38
Pathway
T-cell
MCL
Development Pipeline
Preclinical
~Dec 2016
→ ~Mar 2018
Phase 1
~Jun 2018
→ ~Sep 2019
Phase 2
~Dec 2019
→ ~Mar 2021
Phase 3
Jun 2021
→ Aug 2030
Phase 3Current
NCT07912159
2,097 pts·MCL
2024-12→2027-12·Active
NCT04854586
1,187 pts·MCL
2021-06→TBD·Recruiting
NCT07731218
2,100 pts·MCL
2022-04→2030-08·Completed
+1 more trial
7,024 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-06-263mo awayPh3 Readout· MCL
2027-12-221.7y awayPh3 Readout· MCL
2030-08-064.4y awayPh3 Readout· MCL
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Recruit…
P3
Recruit…
P3
Complet…
P3
Active
Catalysts
Ph3 Readout
2026-06-26 · 3mo away
MCL
Ph3 Readout
2027-12-22 · 1.7y away
MCL
Ph3 Readout
2030-08-06 · 4.4y away
MCL
RecruitingActiveCompleted|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07912159 | Phase 3 | MCL | Active | 2097 | CR |
| NCT04854586 | Phase 3 | MCL | Recruiting | 1187 | EFS |
| NCT07731218 | Phase 3 | MCL | Completed | 2100 | HAM-D |
| NCT07141401 | Phase 3 | MCL | Recruiting | 1640 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 |