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

NCT07502118 | Recruiting Phase 2 DMC

• 1 other identifier: TSB-NexCar19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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

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)

Keywords

Relapsed/Refractory B-Cell Malignancies; B-Cell Acute Lymphoblastic Leukemia (B-ALL); Non-Hodgkin Lymphoma; High-Grade Lymphoma; Low-Grade Lymphoma; CD19; CAR-T Cell Therapy; Talikabtagene Autoleucel; Autologous T Cells; Adoptive Cell Therapy; Cytokine Release Syndrome (CRS); ICANS

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) to CD19 CAR-T cell product at Day 28 post-infusion

  Evaluation of Overall Response Rate (ORR) at Day 28 following infusion of the CD19 CAR-T cell product: In patients with relapsed/refractory (r/r) B-ALL, response will be assessed by morphological bone marrow (BM) analysis at Day 28, and minimal residual disease (MRD) will be evaluated using flow cytometry. In patients with relapsed/refractory (r/r) B-cell lymphoma, treatment response will be assessed by PET/CT according to the Lugano criteria. Duration of Response (DoR): Defined as the time from the date of first documented response to the date of disease progression or death, whichever occurs first.

  Day 28 post-infusion

Secondary Outcomes (11)

• Complete Remission (CR) Rate

  Day 90 and Day 180 after CAR-T cell infusion

• Overall Response Rate (ORR)

  Day 90 and Day 180 after CAR-T cell infusion

• Incidence of Cytokine Release Syndrome (CRS) and associated serum cytokine profile within 10 days post-infusion

  Within 10 days post-infusion

• Incidence and duration of B-cell lymphopenia and hypogammaglobulinemia

  Up to 2 years post-infusion

• Proportion of participants with sustained disease control at Year 1 and Year 2 post CAR-T infusion

  1 year and 2 years post-infusion

Study Arms (1)

Single Arm - Open Label Study

EXPERIMENTAL

Talikabtagene Autoleucel (NexCAR19) CAR-T Cell Therapy

Biological: Talikabtagene Autoleucel

Interventions

Talikabtagene Autoleucel BIOLOGICAL

Talikabtagene Autoleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy. Peripheral blood mononuclear cells are collected via leukapheresis, genetically modified to express an anti-CD19 CAR, expanded ex vivo, and infused intravenously after lymphodepleting chemotherapy.

Single Arm - Open Label Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Additionally:
• High-grade lymphoma: 15-22
• Low-grade lymphoma: 23-24
• B-ALL: 25
• 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.

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (4)

Ankara Bilkent City Hospital - Hematology Clinic

Ankara, Turkey (Türkiye)

RECRUITING

Ankara Etlik City Hospital - Hematology Clinic

Ankara, Turkey (Türkiye)

RECRUITING

Hacettepe University Faculty of Medicine - Department of Internal Medicine, Division of Hematology

Ankara, Turkey (Türkiye)

NOT YET RECRUITING

University of Health Sciences Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Burkitt Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Recurrence; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Study Officials

• Duygu Özel Demiralp DEMIRALP, Prof. MD

  Health Institutes of Turkey

  STUDY DIRECTOR

• Burak Civelek CIVELEK, Prof. MD

  Health Institutes of Turkey

  STUDY DIRECTOR

Central Study Contacts

Funda Ceran Ankara Bilkent City Hospital - Hematology Clinic, Prof. MD

CONTACT

+90 (312) 552 60 00; ceranf@gmail.com

Şule Mine Bakanay Öztürk Ankara Bilkent City Hospital - Hematology Clinic, Prof. MD

CONTACT

+90 (312) 552 60 00; sulemine.ozturk@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a single-arm, open-label, multicenter Phase 2-3 study in which all enrolled participants receive a single infusion of CD19 CAR-T cells (Talikabtagene Autoleucel). There is no randomization or comparator arm.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 30, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)