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RecruitingPhase 2NCT06486051

A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma

Trial Parameters

ConditionLarge B-cell Lymphoma
SponsorMalaghan Institute of Medical Research
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment60
SexALL
Min Age18 Years
Max Age75 Years
Start Date2024-07-12
Completion2026-06-30
Interventions
FludarabineCyclophosphamideWZTL-002 CAR T-cells

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Brief Summary

The goal of this clinical trial is to learn if a new type of chimeric antigen receptor (CAR) T-cell therapy called WZTL-002 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 WZTL-002 treatment? * What is the risk of altered brain function (neurotoxicity) after WZTL-002? All eligible participants will receive WZTL-002; 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 WZTL-002 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 WZTL-002 CAR T-cells to check if the treatment has worked

Eligibility Criteria

Inclusion Criteria: 1. Age 18 to 75 years (inclusive) at the time of informed consent 2. Signed written informed consent for this trial 3. Biopsy-proven relapsed or treatment-refractory B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours * Large B-cell lymphomas of the following histological subtypes: * Diffuse LBCL, not otherwise specified * Diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements * Large B-cell lymphoma with IRF4 rearrangement * High grade B-cell lymphoma with 11q aberrations * High grade B-cell lymphoma, not otherwise specified * Primary mediastinal large B-cell lymphoma * Follicular large B-cell lymphoma * EBV-positive diffuse large B-cell lymphoma, not otherwise specified * Diffuse large B-cell lymphoma associated with chronic inflammation * Primary cutaneous DLBCL, leg type * Large B-cell lymphoma of one of the above subtypes that has transformed from follicular or m

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