# Obecabtagene autoleucel

Source: https://onco.cc/drugs/obecabtagene-autoleucel/  
OnCo record `obecabtagene-autoleucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A CD19 CAR-T built to grip and release quickly, which cut severe side effects and gave adults with relapsed ALL a real chance at durable remission.

## Summary

FELIX (n=127 infused): ORR 77%, CR 55%, median EFS 11.9 months, with grade ≥3 CRS 2.4% and grade ≥3 ICANS 7%, far lower than first-generation CD19 CARs; longer follow-up shows ~40% event-free at 2 years, most without transplant. Approved 8 November 2024 (US) for adults with relapsed/refractory B-ALL, without a REMS. The low-affinity, fast-off-rate binder (CAT) reduces exhaustion and cytokine release.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Aucatzyl
- Code: obe-cel, AUTO1
- Modality: CAR-T (CD19, fast off-rate)
- Mechanism: Autologous T cells with a CD19 CAR using the CAT scFv (fast target dissociation), 4-1BB costimulation; split-dose infusion by marrow blast burden.
- Approvals: US 2024: Relapsed or refractory B-cell precursor ALL, adults; EU 2025: Relapsed or refractory B-ALL, adults ≥26 years
- Dosing: IV, split infusion; Total 410 × 10^6 CAR+ cells given on day 1 and day 10; day-1 fraction depends on marrow blasts (≤20% vs >20%)
- Toxicity (grade 3+): Cytokine release syndrome 2.4%; ICANS 7%

## Sources

- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Obecabtagene%20autoleucel

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Childhood cancers (all types)](https://onco.cc/cancers/childhood-cancers/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/), [Relapsed and refractory acute lymphoblastic leukaemia in children](https://onco.cc/cancers/all-paediatric-relapsed/)
- technologies: [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- companies: [Autolus Therapeutics](https://onco.cc/companies/autolus/)
- terms: [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/)
- trials: [FELIX](https://onco.cc/trials/felix/)
- key papers: [ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL](https://onco.cc/key-papers/paper-eliana-tisagenlecleucel-nejm-2018/)

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