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
Age 18 to 75 years (inclusive) at the time of informed consent
Signed written informed consent for this trial
Biopsy-proven relapsed or treatment-refractory B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours
Diffuse LBCL, not otherwise specified
Active central nervous system (CNS) involvement by lymphoma. In patients with a history of CNS disease or a clinical suspicion of current CNS disease, lumbar puncture and MRI brain must be performed within 30 days of enrolment to exclude current CNS involvement.
Active CNS pathology including: epilepsy, seizure within the preceding year, aphasia, paresis, stroke, dementia, psychosis within the preceding year, severe brain injury, Parkinson disease, or cerebellar disease
Richter transformation of chronic lymphocytic leukaemia
T-cell/histiocyte rich LBCL
Malaghan Institute of Medical Research
Lead sponsor
BioOra Limited
Collaborator
Wellington Zhaotai Therapies Limited
Collaborator