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

NCT06486051 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-03

No results posted yet for this study

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

Conditions

  • Large B-cell Lymphoma
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Primary Mediastinal Large B-cell Lymphoma (PMBCL)
  • Transformed Non-Hodgkin Lymphoma

Interventions

DRUG

Fludarabine

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

DRUG

Cyclophosphamide

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

BIOLOGICAL

WZTL-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.

Sponsors & Collaborators

  • BioOra Limited

    collaborator UNKNOWN

  • Wellington Zhaotai Therapies Limited

    collaborator INDUSTRY

  • Malaghan Institute of Medical Research

    lead OTHER

Principal Investigators

  • Philip George, MBChB · Te Whatu Ora Health New Zealand, Capital Coast & Hutt Valley

  • Robert Weinkove, PhD · Malaghan Institute of Medical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2026-06-30
Completion
2028-06-30

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486051 on ClinicalTrials.gov