OncoMatch/Clinical Trials/NCT06486051
A Study of Atlacabtagene Autoleucel CAR T-cells for Adults With Relapsed Large B-cell Lymphoma
Is NCT06486051 recruiting? Yes, currently enrolling (Sep 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 atlacabtagene autoleucel 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 atlacabtagene autoleucel treatment? * What is the risk of altered brain function (neurotoxicity) after atlacabtagene autoleucel? All eligible participants will receive atlacabtagene autoleucel; 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 atlacabtagene autoleucel 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 atlacabtagene autoleucel 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
Biomarker criteria
Required: MYC rearrangement
Diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements
Required: BCL2 rearrangement
Diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements
Required: IRF4 rearrangement
Large B-cell lymphoma with IRF4 rearrangement
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: chemoimmunotherapy (anthracycline and anti-CD20 monoclonal antibody) — first-line lymphoma therapy for qualifying histology
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: 3 or more prior lines of therapy for LBCL
Patient has received 3 or more prior lines of therapy for LBCL
Cannot have received: gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy
Prior treatment with: gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy
Lab requirements
Blood counts
Neutrophils ≥ 1.0 × 10^9/L, Platelets ≥ 75 × 10^9/L, Lymphocytes ≥ 0.3 × 10^9/L
Kidney function
eCrCl or eGFR ≥ 45 mL/min
Liver function
serum bilirubin < 2.5 × ULN (unless attributable to Gilbert's syndrome) and ALT/AST < 3 × ULN
Cardiac function
LVEF ≥ 40% by echocardiogram or MUGA within 28 days of 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 eCrCl or eGFR ≥ 45mL/min; Adequate hepatic function, defined by serum bilirubin < 2.5 × ULN (unless attributable to Gilbert's syndrome) and ALT/AST < 3 × ULN; Adequate cardiac function, defined as LVEF ≥ 40% by echocardiogram or MUGA within 28 days of 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 3 or more prior lines of therapy for LBCL, gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy disqualifies patients from enrollment.
Does this trial require MYC?
Yes, MYC rearrangement is a required biomarker for enrollment.
Does this trial require BCL2?
Yes, BCL2 rearrangement is a required biomarker for enrollment.
Does this trial require IRF4?
Yes, IRF4 rearrangement is a required biomarker for 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