Actively Recruiting
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
Led by Malaghan Institute of Medical Research · Updated on 2026-03-03
60
Participants Needed
3
Research Sites
104 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
Researchers are studying a new type of chimeric antigen receptor CAR T-cell therapy called WZTL-002 to see if it is effective and safe for treating adults with relapsed or refractory large B-cell lymphoma LBCL who have not responded to or have relapsed after standard chemotherapy. This phase 2 trial aims to evaluate the complete response rate of the lymphoma and the risk of neurotoxicity after treatment with WZTL-002. The study will enroll about 60 participants and compare results to historical patient groups treated with similar therapies. Participants will undergo a procedure called leukapheresis to collect their white blood cells, which are then modified to create the WZTL-002 CAR T-cells. Before receiving the CAR T-cells, patients will have lymphodepleting chemotherapy with fludarabine and cyclophosphamide for three days. On day 0, a single intravenous dose of WZTL-002 CAR T-cells will be given. The dose is based on body weight, with a cap for heavier participants. The treatment period includes close monitoring for 14 days for specific side effects such as cytokine release syndrome and neurotoxicity. Scans using PETCT and CT will be performed before treatment and at multiple points up to 24 months after treatment to evaluate response and duration. During the study, participants will have regular scans, blood tests, and assessments to monitor the treatments effects and safety. Samples will be collected to measure how the CAR T-cells behave in the body and how long their effects last. Adverse events and quality of life will be monitored for up to two years. After 24 months, participants may continue follow-up in long-term registries and studies. The total participation time includes treatment, close monitoring, and extended follow-up for safety and effectiveness assessments.
CONDITIONS
Brief 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 informed consent
- Signed written informed consent
- Biopsy-proven relapsed or treatment-refractory B-cell non-Hodgkin lymphoma of specified large B-cell lymphoma subtypes
- Received at least 2 cycles of standard first-line chemotherapy with an anthracycline and anti-CD20 monoclonal antibody
- Relapsed or refractory disease within 12 months of first-line therapy or after second-line therapy with specific criteria
- PET positive disease by Lugano 2014 criteria
- Available tumor tissue for central review
- Life expectancy of at least 12 weeks related to lymphoma and at least 12 months for other conditions
- ECOG performance status 0 or 1
- Adequate blood counts: neutrophils ≥1.0 x10^9/L, platelets ≥75 x10^9/L, lymphocytes ≥0.3 x10^9/L
- Adequate kidney function with creatinine clearance or GFR ≥45 mL/min
- Adequate liver function: bilirubin <2.5 x ULN unless Gilbert's syndrome, ALT and AST <3 x ULN
- Adequate lung function: grade ≤1 dyspnea and oxygen saturation ≥92% on room air
- Adequate heart function with LVEF ≥40% within 28 days of screening
- For females of reproductive potential: agree to use contraception from enrollment until 12 months after treatment or be not of reproductive potential
- For males: agree to use condoms during chemotherapy, use contraception with female partners of reproductive potential until 12 months after treatment, and not donate sperm for 12 months
- Agree not to donate blood components after receiving WZTL-002
You will not qualify if you...
- Active central nervous system involvement by lymphoma or active CNS pathology such as epilepsy, recent stroke, dementia, or severe brain injury
- Certain lymphoma subtypes excluded, including Richter transformation, T-cell/histiocyte rich LBCL, primary LBCL of immune-privileged sites, Burkitt lymphoma, and others
- Received 3 or more prior lines of therapy for LBCL
- Need for urgent lymphoma therapy due to tumor-related symptoms or risk of compression
- Active autoimmune disease needing systemic immunosuppression
- Active sarcoidosis
- Prior solid organ or allogeneic stem cell transplantation
- Peripheral blood CD3+ T cells <150/µL
- History of active malignancy other than B-cell malignancy within 2 years except certain treated local cancers
- Prior gene therapy, CD19-targeted immunotherapy, purine analogues or other specific treatments within defined timeframes
- Pregnant or lactating female
- Known sensitivity to immunoglobulin or study components
- Current or prior HIV infection
- Recent vaccination with live virus within 4 weeks
- Uncontrolled systemic infection
- Active hepatitis B or C infection not meeting specific criteria
- NYHA class 2 or higher cardiac symptoms or recent significant cardiac events
- Significant illnesses making participation unsuitable
- Inability to provide informed consent
- No consent to enroll in international cellular therapy registry
Research Team
B
Brittany Lavender
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here