RecruitingPhase 2NCT06486051

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)


Sponsor

Malaghan Institute of Medical Research

Enrollment

60 participants

Start Date

Jul 12, 2024

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of immune cell therapy called WZTL-002 CAR T-cells — immune cells that have been engineered to target and destroy large B-cell lymphoma — in adults whose lymphoma has come back or has not responded to previous treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with a specific subtype of large B-cell lymphoma confirmed by biopsy, and it has relapsed or was resistant to prior treatments - You have received adequate first-line treatment for your lymphoma - You meet the health and organ function requirements **You may NOT be eligible if...** - Your lymphoma subtype is not one of the eligible B-cell lymphoma types listed in the study - You have not received any prior treatment - You have severe organ dysfunction or other serious conditions that would prevent safe participation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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.

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Interventions

DRUGFludarabine

30 mg/m\^2/day IV for three consecutive days

DRUGCyclophosphamide

500 mg/m\^2/day IV for three consecutive days

BIOLOGICALWZTL-002 CAR T-cells

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)

Christchurch Hospital

Christchurch, Christchurch Central, New Zealand

Wellington Hospital

Newtown, Wellington Region, New Zealand

Auckland City Hospital

Auckland, New Zealand

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NCT06486051


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