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NCT06799221
Expanded Access Program for OOS Obe-cel
trial testing Out-of-specification obecabtagene autoleucel in Lymphoblastic Leukemia, Acute, Adult. Available.
Quick facts
| Lead sponsor | Autolus Limited |
|---|---|
| Status | AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 32 locations across United States |
Drugs / interventions tested
- Out-of-specification obecabtagene autoleucel — full drug profile →
Conditions studied
- Lymphoblastic Leukemia, Acute, Adult — all drugs for Lymphoblastic Leukemia, Acute, Adult →
- B Cell ALL — all drugs for B Cell ALL →
Sponsor
Autolus Limited — full company profile →
Who can join
18 and older, any sex, with Lymphoblastic Leukemia, Acute, Adult or B Cell ALL. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this program is to provide access to obe-cel treatment for adult patients with ALL who have undergone leukapheresis and had obe-cel manufactured from their blood cells but the product is deemed OOS (does not meet the specifications to be used commercially). The target patients for this study have limited options for treatment and repeat blood sampling is not feasible. The main aims of this study are (1) to provide adult patients with ALL with access to obe-cel and (2) to describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary cancers, and any side effects) within the first 45 days after infusion of OOS obe-cel. This study is a single-arm, open-label, multicenter expanded access program (EAP). The patient population included in this EAP will be adult patients diagnosed with recurring or refractory ALL who were prescribed obe-cel as part of their standard of care and are eligible for use under the approved local prescribing information. To be in the study, patients must provide informed consent, be at least 18 years of age, have a confirmed diagnosis of ALL, be medically fit and stable to receive obe-cel, have had commercial obe-cel prescribed by their treating physician as per standard of care, and for whom remanufacturing is not clinically appropriate. Patients cannot be in the study if they have a history of severe immediate allergic reaction to any drugs or metabolites of similar chemical classes as obe-cel, are a pregnant woman, or are receiving treatment in another study. All data will be collected from information routinely recorded in the medical record. There is no formal hypothesis testing. Data will be analyzed descriptively (numbers, percentages and ranges, etc.).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06799221
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Autolus Limited trials
Trials by the same sponsor.
- NCT07139743 — Obe-cel in Refractory Progressive Forms of Multiple Sclerosis · Phase 1 · recruiting
- NCT04404660 — A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leu · Phase 1, PHASE2 · active not recruiting
- NCT03590574 — Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma · Phase 1, PHASE2 · terminated
- NCT03287817 — Cluster of Differentiation Antigen 19/22(CD19/22) CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma · Phase 1, PHASE2 · terminated
- NCT03289455 — CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL) · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06799221 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Autolus Limited
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06799221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing