Actively Recruiting
NexCAR19 (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies (NexCAR19)
Led by Health Institutes of Turkey · Updated on 2026-03-30
40
Participants Needed
4
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NexCAR19 (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies (NexCAR19)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Approved for leukapheresis by the CAR-T cell treatment council
- ECOG performance status less than 2
- Life expectancy of at least 12 weeks
- Estimated creatinine clearance of 60 mL/min or higher (or 30-60 mL/min if bendamustine is used)
- Liver function with ALT and AST less than or equal to 3 times the upper limit of normal unless due to underlying cancer
- Total bilirubin less than or equal to 2 times upper limit of normal except certain conditions
- Hemodynamically stable with left ventricular ejection fraction 45% or higher
- Baseline oxygen saturation above 92% on room air
- Absolute neutrophil count 500/μL or higher (may be waived for cancer-related cytopenia)
- Platelet count 50,000/μL or higher (may be waived for cancer-related cytopenia)
- Negative pregnancy test within 24 hours before conditioning therapy and before leukapheresis for women of childbearing potential
- Use of highly effective contraception for at least 12 months after CAR-T infusion for sexually active patients
- Written informed consent provided
- Additional specific criteria for high-grade lymphoma, other B-cell lymphomas, and B-ALL as defined in the protocol
You will not qualify if you...
- Uncontrolled life-threatening infection
- HIV positive status
- Active hepatitis B or C infection
- Unstable angina or myocardial infarction within 6 months
- Uncontrolled cardiac arrhythmia
- Concurrent malignancy except certain treated skin cancers and resected malignancies in remission for 3 years
- Pregnant or breastfeeding
- Hypersensitivity to CAR-T product components
- Active autoimmune or inflammatory neurological disorders
- Primary immunodeficiency
- Short-acting leukemia or lymphoma therapies not stopped more than 72 hours before leukapheresis and infusion
- Burkitt lymphoma or leukemia diagnosis
- Steroids not discontinued more than 72 hours prior except low dose allowed
- Investigator assessment of inability to comply
- Additional exclusions for high-grade lymphoma including active CNS involvement, prior allogeneic stem cell transplant, recent immunosuppressive therapy, and recent radiation or chemotherapy as specified
- Additional exclusions for low-grade lymphoma including recent live vaccine and tumor mass effect requiring urgent treatment
- Additional exclusion for B-ALL including active acute graft-versus-host disease requiring systemic treatment within 4 weeks prior to enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Ankara Bilkent City Hospital - Hematology Clinic
Ankara, Turkey (Türkiye)
Actively Recruiting
2
Ankara Etlik City Hospital - Hematology Clinic
Ankara, Turkey (Türkiye)
Actively Recruiting
3
Hacettepe University Faculty of Medicine - Department of Internal Medicine, Division of Hematology
Ankara, Turkey (Türkiye)
Not Yet Recruiting
4
University of Health Sciences Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
Research Team
F
Funda Ceran Ankara Bilkent City Hospital - Hematology Clinic, Prof. MD
CONTACT
Ş
Şule Mine Bakanay Öztürk Ankara Bilkent City Hospital - Hematology Clinic, Prof. MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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