Drug · Gene Therapy
Obecabtagene Autoleucel
CI-DRUG-00000807Explore in graph →CHEMBL5095440 Approved
Regulatory
Approvals (1)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | B Acute Lymphoblastic Leukemia | Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).conditional | approved | Jul 17, 2025 | ema |
Data updated 14 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 2 | 4 | 3 | 0 | 4 | 1 | EU | Jul 17, 2025 | Jun 3, 2020 |
| Leukemia | Approved | Phase 2 | 2 | 2 | 0 | 2 | 1 | EU | Jul 17, 2025 | Aug 26, 2025 |
| Non-Hodgkin Lymphoma | Phase2 | Phase 2 | 1 | 0 | 0 | 1 | 0 | — | — | Jun 3, 2020 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (4)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06173518 | A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL) | recruiting | Phase 1 | 30 | Autolus LimitedINDUSTRY | 3 | Sep 16, 2026 | clinicaltrials |
| NCT07400029 | A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia | recruiting |