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NCT06486051 · ClinicalTrials.gov record · last posted 2026-08-07

A Study of Atlacabtagene Autoleucel CAR T-cells for Adults With Relapsed Large B-cell Lymphoma

Study acronym: ENABLE-2
StatusRecruiting
PhasePhase 2
Started2024-07-12
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from the ClinicalTrials.gov record
The goal of this clinical trial is to learn if a new type of chimeric antigen receptor (CAR) T-cell therapy called atlacabtagene autoleucel is effective and safe for the treatment large B-cell lymphomas (LBCL) that have not responded to or have come back after standard chemotherapy. The main questions this trial aims to answer are: * What is the likelihood of complete response of the lymphoma after atlacabtagene autoleucel treatment? * What is the risk of altered brain function (neurotoxicity) after atlacabtagene autoleucel? All eligible participants will receive atlacabtagene autoleucel; the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies. Participants will: * Have a procedure to gather white blood cells * Receive chemotherapy to prepare for the CAR T-cells * Receive atlacabtagene autoleucel CAR T-cells through a vein * Be monitored closely for the first 14 days for certain side effects * Have scans 28 days and 3, 6, 12 and 24 months after atlacabtagene autoleucel CAR T-cells to check if the treatment has worked

Protocol amendment history 2 changes detected by DataLookout

2026-08-08
critical
Primary completion pushed: 2026-06-30 → 2027-06-30
2026-08-08
minor
Completion pushed: 2028-06-30 → 2029-06-30
Trial Details
NCT Number NCT06486051
Lead Sponsor Malaghan Institute of Medical Research
Collaborators: BioOra Limited, Wellington Zhaotai Therapies Limited
Conditions Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Transformed Non-Hodgkin Lymphoma
Enrollment 60 participants
Start Date 2024-07-12
Primary Completion 2027-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-07