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 (May 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
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
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.
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