NexCAR19 (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies (NexCAR19)

Recruiting now · Phase 2/Phase 3

Conditions studied: Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), Relapsed/Refractory Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBCL), Follicular Lymphoma ( FL)

In brief

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.

Key facts

Study ID

NCT07502118

Run by

Health Institutes of Turkey

People needed

40

Starts

2025-09-11

Expected to finish

2030-01-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All participants must meet Inclusion Criteria 1-13.
• Additionally:
• High-grade lymphoma subjects must meet Criteria 14-18.
• Other B-cell lymphoma subjects must meet Criteria 19-24.
• B-ALL subjects must meet Criteria 25-29.
• General Inclusion Criteria (Applicable to All Cohorts)
• Age ≥18 years.
• Patients approved for leukapheresis by the CAR-T cell treatment council.
• ECOG performance status <2.
• Life expectancy ≥12 weeks.
• Renal Function: Estimated creatinine clearance ≥60 mL/min (Cockcroft-Gault) → fludarabine/cyclophosphamide lymphodepletion.
• In lymphoma cohort patients with creatinine clearance 30-60 mL/min, bendamustine may be used as an alternative due to cumulative fludarabine toxicity and neurotoxicity risk.
• 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).
• Baseline oxygen saturation >92% on room air.
• 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).
• Negative serum or urine pregnancy test (within 24 hours prior to conditioning therapy) in women of childbearing potential; also negative prior to leukapheresis.
• Sexually active patients (women of childbearing potential and all men) must use highly effective contraception for ≥12 months after CAR-T infusion.
• Written informed consent provided.
• High-Grade Lymphoma - Additional Inclusion Criteria (14-18)
• Histologically confirmed previously treated:
• Diffuse large B-cell lymphoma (DLBCL)

You may not qualify if…

• All participants must meet Exclusion Criteria 1-14.
• Additionally:
• High-grade lymphoma: 15-22
• Low-grade lymphoma: 23-24
• B-ALL: 25
• General Exclusion Criteria (All Cohorts)
• Uncontrolled life-threatening infection (e.g., positive blood culture ≤72h before infusion).
• HIV positive.
• Active HBV replication or active HCV (RNA positive).
• Unstable angina or MI within 6 months.
• Uncontrolled cardiac arrhythmia.
• Concurrent malignancy except adequately treated non-melanoma skin cancer, in situ carcinoma (≥3 years disease-free), or completely resected malignancy in CR ≥3 years.
• Pregnant or breastfeeding.
• Hypersensitivity to CAR-T product excipients.
• Active autoimmune/inflammatory neurologic disorders.
• Primary immunodeficiency.
• Short-acting leukemia/lymphoma therapies must be stopped >72h before leukapheresis and infusion.
• Burkitt lymphoma/leukemia.
• Steroids must be discontinued >72h prior (<12 mg/m²/day hydrocortisone equivalent allowed).
• Investigator deems subject unable to comply.
• High-Grade Lymphoma - Additional Exclusion (15-22)
• Active CNS involvement.
• Prior allogeneic HSCT.
• Systemic immunosuppressives not discontinued ≥1 weeks before leukapheresis/infusion.
• Anti-proliferative therapy not stopped ≥1 weeks prior.

Where it is running

• Ankara Bilkent City Hospital - Hematology Clinic — Ankara, Turkey (Türkiye) (enrolling)
• Ankara Etlik City Hospital - Hematology Clinic — Ankara, Turkey (Türkiye) (enrolling)
• University of Health Sciences Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital — Ankara, Turkey (Türkiye) (enrolling)
• Hacettepe University Faculty of Medicine - Department of Internal Medicine, Division of Hematology — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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