Actively Recruiting
A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma
Led by Malaghan Institute of Medical Research · Updated on 2026-03-03
60
Participants Needed
3
Research Sites
207 weeks
Total Duration
On this page
Sponsors
M
Malaghan Institute of Medical Research
Lead Sponsor
B
BioOra Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at time of consent
- Signed written informed consent
- Biopsy-confirmed relapsed or refractory B-cell non-Hodgkin lymphoma of specified large B-cell lymphoma subtypes
- Received at least 2 cycles of standard first-line chemoimmunotherapy including an anthracycline and anti-CD20 antibody
- Relapsed or refractory disease within 12 months of first-line therapy or following second-line therapy with specific criteria
- PET-positive disease per Lugano 2014 criteria
- Available tumor tissue for central review
- Lymphoma-related life expectancy at least 12 weeks and other conditions life expectancy at least 12 months
- ECOG performance status of 0 or 1
- Adequate blood counts: neutrophils ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L, lymphocytes ≥ 0.3 x 10^9/L
- Adequate kidney function with eCrCl or eGFR ≥ 45 mL/min
- Adequate liver function with bilirubin < 2.5 x ULN (unless Gilbert's syndrome) and ALT/AST < 3 x ULN
- Adequate lung function defined as ≤ Grade 1 dyspnoea and oxygen saturation ≥ 92% on room air
- Adequate heart function with LVEF ≥ 40% within 28 days before screening
- Female participants must agree to use condoms during lymphodepleting chemotherapy and highly effective contraception for 12 months after treatment or be not of reproductive potential
- Male participants must agree to use condoms during lymphodepleting chemotherapy, use effective contraception if partner is of reproductive potential for 12 months after treatment, and not donate sperm for 12 months after treatment
- Agree not to donate blood after receiving WZTL-002
You will not qualify if you...
- Active central nervous system lymphoma involvement
- Active CNS conditions including epilepsy, recent seizures, aphasia, paresis, stroke, dementia, psychosis, severe brain injury, Parkinson disease, or cerebellar disease
- Specific B-cell lymphoma subtypes excluded as per 2022 WHO classification
- Received 3 or more prior therapy lines for LBCL
- Need for urgent lymphoma therapy due to tumor-related symptoms or risk of compression
- Active autoimmune disease requiring systemic immunosuppression
- Active sarcoidosis
- Prior solid organ or allogeneic stem cell transplant
- Peripheral blood CD3+ T cells < 150/μL
- History of active non-B-cell malignancy within 2 years except certain treated localized cancers
- Prior gene therapy, CD19-targeted immunotherapy, recent purine analogues, bispecific T-cell engagers, radiotherapy, investigational drugs, chemotherapy, corticosteroids, monoclonal antibodies within specified time frames
- Pregnant or lactating females
- Known sensitivity to immunoglobulin or investigational product components
- Current or prior HIV infection
- Live virus vaccination within 4 weeks prior to enrollment
- Inadequately controlled systemic infection
- Active hepatitis B or C infection with specific criteria
- NYHA class 2 or higher cardiac symptoms or recent major cardiac events
- Significant other illnesses making trial participation unsuitable
- Unable to provide informed consent
- Decline participation in cellular therapy registry
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Christchurch Hospital
Christchurch, Christchurch Central, New Zealand, 8011
Actively Recruiting
2
Wellington Hospital
Newtown, Wellington Region, New Zealand, 6021
Actively Recruiting
3
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
Research Team
B
Brittany Lavender
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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