FELIX
The trial that showed a gentler CAR-T design could treat adult ALL with a fraction of the severe side effects.
127 infused: ORR 77%, CR 55%, median EFS 11.9 months; grade ≥3 CRS 2.4%, grade ≥3 ICANS 7%; ~40% event-free at 24 months, most without consolidative transplant. NEJM 2024 (Roddie et al.). FDA approval 8 November 2024 without a REMS.
- 77 out of 100 people reached this endpoint with Obe-cel.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- 55 out of 100 people had no sign of cancer on scans or tests with Obe-cel.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- Median 11.9 months with Obe-cel.
- A median is a midpoint: half the people did better than this and half did worse.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Relapsed or refractory B-ALL, adults: obecabtagene autoleucel single split-dose course. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
153 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall remission (CR + CRi)primary | Obe-cel | 127 | 77% | — | — | link |
| Complete remission | Obe-cel | — | 55% | — | — | — |
| Event-free survival (median) | Obe-cel | — | 11.9 months | — | — | — |
Pages like this
not linked directly; found by shared links- CompanyAutolus Therapeutics
Shares Obecabtagene autoleucel, Acute lymphoblastic leukaemia.
- PersonJae H. Park
Shares CD19, Acute lymphoblastic leukaemia, CAR-T cell therapy.
- PersonRenier J. Brentjens
Shares CD19, Acute lymphoblastic leukaemia, CAR-T cell therapy.
- PersonNirali N. Shah
Shares CD19, Acute lymphoblastic leukaemia, CAR-T cell therapy.
- TrialTRANSCEND CLL 004
Shares CD19, CAR-T cell therapy.
- IdeaNon-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route
Shares CD19, CAR-T cell therapy.
- ProductBrexucabtagene autoleucel
Shares CD19, Acute lymphoblastic leukaemia, CAR-T cell therapy.
- IdeaNon-profit, open-licence lentiviral vectors and producer cell lines for CAR-T
Shares CD19, CAR-T cell therapy.