OncoMatch/Clinical Trials/NCT04094311

Study of Out of Specification for Tisagenlecleucel

Is NCT04094311 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies CTL019 for b-cell acute lymphoblastic leukemia.

Phase 3RecruitingNovartis PharmaceuticalsNCT04094311Data as of May 2026

Treatment: CTL019 — This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.

Check if I qualify

Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify