OncoMatch/Clinical Trials/NCT07502118
NexCAR19 (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies (NexCAR19)
Is NCT07502118 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Talikabtagene Autoleucel for relapsed/refractory b-cell acute lymphoblastic leukemia (b-all).
Treatment: Talikabtagene Autoleucel — The NexCAR19 study is a national, open-label, multicenter Phase 2-3 clinical trial designed to evaluate the efficacy and safety of the anti-CD19 chimeric antigen receptor (CAR) T-cell product, Talikabtagene Autoleucel, in patients with relapsed/refractory B-cell malignancies, including B-cell Acute Lymphoblastic Leukemia (B-ALL) and Non-Hodgkin Lymphoma. The study is supported by the Presidency of Turkish Health Institutes (TÜSEB) and will be conducted at four centers. This therapy is based on collecting the patient's own T cells, genetically modifying them in a laboratory to recognize the CD19 antigen, and reinfusing them into the patient. The goal is to target leukemia or lymphoma cells and achieve disease control. The primary objective is to assess the overall response rate at Day 28 after infusion and to evaluate the safety profile of the treatment. Secondary objectives include assessment of complete response rate, duration of response, overall survival, and progression-free survival, as well as the frequency and severity of cytokine release syndrome (CRS), neurotoxicity (ICANS), and other treatment-related adverse events. In addition, the in vivo persistence and immunological effects of CAR-T cells will be evaluated. Eligible patients must be 18 years of age or older, have an adequate performance status, sufficient organ function, and meet disease-specific eligibility criteria. Key exclusion criteria include active severe infection, uncontrolled cardiac disease, active central nervous system involvement (where applicable), HIV or active hepatitis infection, pregnancy, and severe immunodeficiency. The treatment process includes leukapheresis for cell collection, administration of lymphodepleting chemotherapy if required, followed by a single infusion of CAR-T cells. Patients will be closely monitored after infusion, particularly during the early period, and both early and late adverse events, as well as treatment response, will be regularly assessed. A total of 40 patients are planned to be enrolled. The overall clinical follow-up period, including short- and long-term monitoring, is expected to last approximately 30 months. Data will be analyzed using appropriate statistical methods.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 tumor expression documented within 3 months (BM or PB by flow cytometry)
CD19 tumor expression documented within 3 months (BM or PB by flow cytometry)
Required: CCND1 overexpression
Mantle Cell Lymphoma (Cyclin D1 overexpression or t(11;14))
Required: IGH t(11;14)
Mantle Cell Lymphoma (Cyclin D1 overexpression or t(11;14))
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-CD20 antibody — high-grade lymphoma
Must have received anti-CD20 monoclonal antibody
Must have received: anthracycline-containing regimen — high-grade lymphoma
Must have received...anthracycline-containing regimen
Must have received: BTK inhibitor (ibrutinib, acalabrutinib) — mantle cell lymphoma
BTK inhibitor (ibrutinib or acalabrutinib; intolerance allowed)
Cannot have received: anti-CD20 antibody
Exception: minimum interval of ≥4 weeks between DLI and leukapheresis/infusion; applies to prior antibody-based therapies including anti-CD20, anti-CD22, anti-CD79a, and similar agents
A minimum interval of ≥4 weeks is required between donor lymphocyte infusion (DLI) and leukapheresis, and ≥4 weeks between DLI and CAR-T cell infusion. This requirement applies to prior antibody-based therapies, including anti-CD20, anti-CD22, anti-CD79a, and similar agents.
Cannot have received: cytotoxic chemotherapy
Exception: must be stopped ≥1 week prior
Cytotoxic drugs not stopped ≥1 week prior
Cannot have received: systemic immunosuppressive
Exception: not discontinued ≥1 week before leukapheresis/infusion
Systemic immunosuppressives not discontinued ≥1 weeks before leukapheresis/infusion
Cannot have received: anti-proliferative therapy
Exception: not stopped ≥1 week prior
Anti-proliferative therapy not stopped ≥1 weeks prior
Cannot have received: immune checkpoint inhibitor or stimulatory therapy
Exception: ≥3 half-lives elapsed since prior immune checkpoint inhibitor or stimulatory therapy
≥3 half-lives elapsed since prior immune checkpoint inhibitor or stimulatory therapy
Cannot have received: radiation therapy
Exception: not stopped ≥2 days before leukapheresis and ≥1 week before infusion
Radiation not stopped ≥2 days before leukapheresis and ≥1 week before infusion
Cannot have received: live vaccine
Exception: ≤6 weeks before conditioning
Live vaccine ≤6 weeks before conditioning
Lab requirements
Blood counts
ANC ≥500/µL (may be waived if cytopenia due to underlying malignancy at investigator discretion); Platelet count ≥50,000/µL (may be waived if cytopenia due to underlying malignancy at investigator discretion)
Kidney function
Estimated creatinine clearance ≥60 mL/min (Cockcroft-Gault); in lymphoma cohort, bendamustine may be used if CrCl 30-60 mL/min
Liver function
ALT and AST ≤3 × ULN unless attributable to underlying malignancy; Total bilirubin ≤2 × ULN except in Gilbert syndrome, isolated unconjugated hyperbilirubinemia, or if attributable to underlying malignancy
Cardiac function
Hemodynamically stable with LVEF ≥45% (confirmed by echocardiography or MUGA scan)
Renal Function: Estimated creatinine clearance ≥60 mL/min (Cockcroft-Gault)...; Liver Function: ALT and AST ≤3 × ULN unless attributable to underlying malignancy. Total bilirubin ≤2 × ULN except in Gilbert syndrome, isolated unconjugated hyperbilirubinemia, or if attributable to underlying malignancy; Hemodynamically stable with LVEF ≥45% (confirmed by echocardiography or MUGA scan); ANC ≥500/µL (may be waived if cytopenia due to underlying malignancy at investigator discretion); Platelet count ≥50,000/µL (may be waived if cytopenia due to underlying malignancy at investigator discretion)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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