Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID07502118

An Open-Label, Multicenter Phase 2-3 Study of Anti-CD19 CAR-T Cells (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies

Led by Health Institutes of Turkey · Updated on 2026-03-30

40

Participants Needed

4

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating Talikabtagene Autoleucel, an anti-CD19 CAR-T cell therapy, in adults with relapsed or refractory B-cell malignancies such as B-cell Acute Lymphoblastic Leukemia (B-ALL) and Non-Hodgkin Lymphoma. This national, open-label, multicenter Phase 2-3 trial supported by the Turkish Health Institutes aims to assess the treatment's overall response rate 28 days after infusion and to monitor its safety profile. Secondary goals include studying complete remission, survival rates, and treatment-related side effects like cytokine release syndrome and neurotoxicity. The treatment involves collecting the patient's own T cells through leukapheresis, modifying them in the lab to target CD19 on cancer cells, and then reinfusing them after administering lymphodepleting chemotherapy if needed. Patients receive a single infusion of the CAR-T cells. The study includes short-term monitoring especially during the first 10 days post-infusion for side effects, followed by long-term follow-up lasting up to 30 months. Participants will undergo regular assessments including imaging scans, bone marrow evaluation, immune function tests, and laboratory tests to track response and CAR-T cell persistence. Safety monitoring includes watching for adverse events and immune-related effects over time. The overall study duration includes about 6 months for recruitment, 3 months for treatment and early follow-up, and 21 months for long-term monitoring to gather comprehensive data on outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
  • Adequate kidney function (creatinine clearance ≥60 mL/min; bendamustine allowed if 30-60 mL/min)
  • Adequate liver function (ALT and AST ≤3 times upper normal limit; bilirubin ≤2 times upper normal limit with exceptions)
  • Stable heart function with left ventricular ejection fraction ≥45%
  • Baseline oxygen saturation above 92% on room air
  • Adequate blood counts (ANC ≥500/µL and platelets ≥50,000/µL) unless due to malignancy
  • Negative pregnancy test for women of childbearing potential prior to therapy
  • Use of effective contraception for at least 12 months after CAR-T infusion
  • Written informed consent provided
  • Disease-specific criteria for high-grade lymphoma, other B-cell lymphomas, or B-ALL as defined in the protocol
Not Eligible

You will not qualify if you...

  • Uncontrolled severe infection or positive blood culture within 72 hours before infusion
  • HIV positive
  • Active hepatitis B or C infection
  • Unstable angina or heart attack within past 6 months
  • Uncontrolled heart rhythm problems
  • Current other cancers except certain treated skin or in situ cancers disease-free for 3 years
  • Pregnant or breastfeeding
  • Allergy to CAR-T product ingredients
  • Active autoimmune or inflammatory neurological disorders
  • Primary immunodeficiency
  • Recent leukemia/lymphoma treatments not stopped more than 72 hours before leukapheresis
  • Burkitt lymphoma or leukemia
  • Steroid use not stopped more than 72 hours before therapy (low dose allowed)
  • Inability to comply as judged by investigator
  • Disease-specific exclusions including active CNS involvement, prior allogeneic stem cell transplant, recent immunosuppressive or chemotherapy treatments, live vaccines within 6 weeks, and tumor mass effect needing urgent treatment
  • Active graft-versus-host disease requiring recent treatment for B-ALL patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - Up to 3 weeks

Participants undergo leukapheresis to collect peripheral blood mononuclear cells for CAR-T cell manufacturing and receive lymphodepleting chemotherapy if required before infusion.

1 to 2 visits depending on lymphodepletion requirements

Treatment

Duration - Single day

Participants receive a single intravenous infusion of Talikabtagene Autoleucel (CAR-T cells).

1 infusion visit (in-person)

Short-term Follow-up

Duration - 10 days post-infusion

Participants are closely monitored for signs of cytokine release syndrome and neurotoxicity, including clinical response evaluation and safety assessments.

Daily visits or assessments for up to 10 days

Post-treatment Monitoring

Duration - Up to 6 months post-infusion

Participants undergo ongoing clinical response evaluations, imaging, bone marrow assessments, immunological testing, and monitoring of CAR-T cell persistence and expansion.

Regular visits including assessments at Day 28, Day 90, and Day 180 post-infusion

Long-term Follow-up

Duration - Up to 2 years post-infusion

Participants are monitored long-term for survival outcomes, disease control, immunological effects, and CAR-T cell persistence for up to 2 years after infusion.

Periodic visits over 2 years

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

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Research Team

F

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

Ş

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

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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