A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma
A Phase 2 Trial to Evaluate the Efficacy and Safety of WZTL-002 in Patients With Relapsed or Refractory Large B-cell Lymphoma (ENABLE-2)
Malaghan Institute of Medical Research
60 participants
Jul 12, 2024
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
30 mg/m\^2/day IV for three consecutive days
500 mg/m\^2/day IV for three consecutive days
WZTL-002 comprises autologous T-cells transduced to express the third-generation 1928T2z chimeric antigen receptor, which recognises the CD19 antigen present on malignant and normal B-cells. The chimeric antigen receptor (CAR) incorporates an extracellular scFv specific for CD19, the intracellular signalling domains of CD28 and CD3ζ, and an intracellular co-stimulatory domain derived from TLR2 interposed between CD28 and CD3ζ. On Day 0, the WZTL-002 CAR T-cell product is administered intravenously two days after completing lymphodepleting chemotherapy.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06486051