OncoMatch/Clinical Trials/NCT06486051
A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma
Is NCT06486051 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including WZTL-002 CAR T-cells and Fludarabine for large b-cell lymphoma.
Treatment: Fludarabine · Cyclophosphamide · WZTL-002 CAR T-cells — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: chemoimmunotherapy (anthracycline and anti-CD20 monoclonal antibody) — first-line
Received adequate first-line lymphoma therapy for the qualifying histology (as defined in inclusion criterion 3 above), comprising at least 2 cycles of a standard combination regimen incorporating an anthracycline and an anti-CD20 monoclonal antibody
Cannot have received: gene therapy (CAR T-cell therapy)
Prior treatment with: gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy
Cannot have received: CD19-targeted immunotherapy
Prior treatment with: gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy
Cannot have received: purine analogue (bendamustine)
purine analogue (including bendamustine) or alemtuzumab within 6 months of enrolment
Cannot have received: monoclonal antibody (alemtuzumab)
purine analogue (including bendamustine) or alemtuzumab within 6 months of enrolment
Cannot have received: bispecific T-cell engager
bispecific T-cell engager, radiotherapy or an investigational medicine within 4 weeks of enrolment
Cannot have received: radiotherapy
bispecific T-cell engager, radiotherapy or an investigational medicine within 4 weeks of enrolment
Cannot have received: investigational medicine
bispecific T-cell engager, radiotherapy or an investigational medicine within 4 weeks of enrolment
Cannot have received: cytotoxic chemotherapy
cytotoxic chemotherapy, systemic corticosteroids (at doses of ≥ 10 mg prednisone daily or equivalent), monoclonal antibody or antibody-drug conjugate (other than alemtuzumab) within 2 weeks of enrolment
Cannot have received: systemic corticosteroids
cytotoxic chemotherapy, systemic corticosteroids (at doses of ≥ 10 mg prednisone daily or equivalent), monoclonal antibody or antibody-drug conjugate (other than alemtuzumab) within 2 weeks of enrolment
Cannot have received: monoclonal antibody
Exception: other than alemtuzumab
cytotoxic chemotherapy, systemic corticosteroids (at doses of ≥ 10 mg prednisone daily or equivalent), monoclonal antibody or antibody-drug conjugate (other than alemtuzumab) within 2 weeks of enrolment
Cannot have received: antibody-drug conjugate
Exception: other than alemtuzumab
cytotoxic chemotherapy, systemic corticosteroids (at doses of ≥ 10 mg prednisone daily or equivalent), monoclonal antibody or antibody-drug conjugate (other than alemtuzumab) within 2 weeks of enrolment
Lab requirements
Blood counts
Neutrophils ≥ 1.0 × 10^9/L, Platelets ≥ 75 × 10^9/L, Lymphocytes ≥ 0.3 × 10^9/L
Kidney function
estimated creatinine clearance (eCrCl) or glomerular filtration rate (eGFR) ≥ 45mL/min using the Cockroft Gault estimation, CKD-EPI equation or as assessed by direct measurement
Liver function
serum bilirubin < 2.5 × ULN (unless attributable to Gilbert's syndrome) and alanine transaminase and aspartate aminotransferase < 3 × ULN
Cardiac function
left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram or multigated acquisition (MUGA), performed within 28 days of commencing screening
Adequate haematologic function, defined by: Neutrophils ≥ 1.0 × 10^9/L, Platelets ≥ 75 × 10^9/L, Lymphocytes ≥ 0.3 × 10^9/L; Adequate renal function, defined by estimated creatinine clearance (eCrCl) or glomerular filtration rate (eGFR) ≥ 45mL/min using the Cockroft Gault estimation, CKD-EPI equation or as assessed by direct measurement; Adequate hepatic function, defined by serum bilirubin < 2.5 × ULN (unless attributable to Gilbert's syndrome) and alanine transaminase and aspartate aminotransferase < 3 × ULN; Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram or multigated acquisition (MUGA), performed within 28 days of commencing screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06486051 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy, CD19-targeted immunotherapy, purine analogue disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify