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Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)Phase 2/3NexCAR19NCT07502118

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

A Phase 2/3 study testing Talikabtagene Autoleucel in people with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and Relapsed/Refractory Non-Hodgkin Lymphoma, run by Health Institutes of Turkey at 4 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Talikabtagene Autoleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesTurkey (Türkiye)
Study dates
11 Sep 2025to 1 Jan 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 76Show fewer
  • 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)
  • Primary mediastinal B-cell lymphoma
  • Transformed indolent B-cell lymphoma
  • Follicular lymphoma Grade 3B
  • High-grade B-cell lymphoma
  • Chemotherapy-refractory disease defined as:
  • Primary refractory disease
  • Best response to last chemotherapy = PD or SD (biopsy confirmed)
  • Progression/relapse ≤12 months after autologous SCT
  • Relapse ≤12 months after first-line CR (biopsy confirmed)
  • Relapse beyond 12 months if auto-SCT not feasible
  • Not eligible for or unwilling to undergo autologous SCT.
  • Must have received anti-CD20 monoclonal antibody and anthracycline-containing regimen. Transformed lymphoma subjects must have received ≥2 prior systemic lines.
  • Measurable disease per International Working Group (IWG) criteria.
  • Other B-Cell Lymphomas - Additional Inclusion Criteria (19-24)
  • Histologically confirmed:
  • Mantle Cell Lymphoma (Cyclin D1 overexpression or t(11;14))
  • Follicular Lymphoma Grade I-IIIA
  • Marginal Zone Lymphoma
  • Relapsed or refractory disease:
  • MCL: ≤5 prior regimens including:
  • Anthracycline or bendamustine
  • Anti-CD20 antibody
  • BTK inhibitor (ibrutinib or acalabrutinib; intolerance allowed)
  • FL/MZL: Progression after ≥2 combination chemoimmunotherapy regimens (single-agent CD20 or splenectomy not counted).
  • Radiologically measurable disease at screening
  • per revised IWG (Cheson 2007): ≥1 measurable lesion
  • Previously irradiated lesions measurable only if progression documented
  • If only nodal disease: ≥1 node ≥2 cm
  • No known active CNS lymphoma involvement.
  • Prior therapy toxicities resolved to ≤Grade 1 (except alopecia).
  • Prior autologous HCT, POD24 status, and prior PI3K inhibitor therapy allowed.
  • B-Cell Acute Lymphoblastic Leukemia (B-ALL) - Additional Inclusion Criteria (25-29)
  • Relapsed/Refractory B-ALL meeting one of:
  • Primary refractory disease
  • First relapse ≤12 months
  • ≥2 prior systemic lines
  • Post-allogeneic SCT relapse (≥100 days post-transplant; off immunosuppression ≥4 weeks)
  • Ph+ disease:
  • TKI intolerance
  • Relapsed/refractory after ≥2 TKIs
  • No alternative TKI option
  • Ineligible for allogeneic SCT due to
  • comorbidity,
  • conditioning contraindication,
  • no donor,
  • prior SCT,
  • or refusal (documented).
  • Morphological bone marrow disease.
  • CD19 tumor expression documented within 3 months (BM or PB by flow cytometry).
  • Absolute lymphocyte count ≥100/µL.
  • ≥3 half-lives elapsed since prior immune checkpoint inhibitor or stimulatory therapy

Who cannot join

  • 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)
Show all 34Show fewer
  • 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.
  • Cytotoxic drugs not stopped ≥1 week prior.
  • 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.
  • CNS prophylaxis not stopped >1 week prior.
  • Radiation not stopped ≥2 days before leukapheresis and ≥1 week before infusion.
  • Low-Grade Lymphoma - Additional Exclusion (23-24)
  • Live vaccine ≤6 weeks before conditioning.
  • Tumor mass effect requiring urgent treatment.
  • B-ALL - Additional Exclusion (25)
  • Acute graft-versus-host disease (GVHD) of Grade II-IV according to the Glucksberg criteria or Grade B-D according to the IBMTR index; or acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

Turkey (Türkiye)4 sites, 4 recruiting

  • Ankara Bilkent City Hospital - Hematology Clinic

    Ankara

    Funda Ceran, Prof. Dr., +90 (312) 552 60 00, ceranf@gmail.com

    Şule Mine Bakanay Öztürk, Prof. Dr., +90 (312) 552 60 00, sulemine.ozturk@yahoo.com

    Recruiting

  • Ankara Etlik City Hospital - Hematology Clinic

    Ankara

    Ahmet Kürşad Güneş, Assoc. Prof., +90 (0312) 797 00 00, ahmetkgunes@gmail.com

    Şahika Zeynep Akı, Prof. Dr., +90 (0312) 797 00 00, sahikazeynep@gmail.com

    Recruiting

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

    Ankara

    Hakan Göker, Prof. Dr., +90 (312) 305 50 00, hgoker1@yahoo.com

    Elifcan Aladağ Karakulak, Assoc. Prof., +90 (312) 305 50 00, elifcan.aladag@gmail.com

    Not yet recruiting

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

    Ankara

    Fevzi Altuntaş, Prof. Dr., +90 (312) 336 09 09, faltuntas@hotmail.com

    Burcu Aslan Candır, Specialist, +90 (312) 336 09 09, drburcuaslancandir@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: An Open-Label, Multicenter Phase 2-3 Clinical Study of Anti-CD19 Chimeric Antigen Receptor T Cells (Talikabtagene Autoleucel) in Patients With Relapsed/Refractory B-Cell Malignancies (NexCAR19)

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.

Read more

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.

Read the detailed description

This study (NexCAR19) 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) autologous 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 will be conducted at four centers with the support of the Presidency of Turkish Institutes of Health (TÜSEB).

The primary objective is to assess the overall response rate and safety profile of CD19-targeted CAR-T cell therapy. Secondary objectives include evaluation of complete response rates, duration of response, overall survival (OS), event-free survival (EFS), progression-free survival (PFS), relapse-free survival (RFS), as well as the incidence and severity of cytokine release syndrome (CRS) and neurotoxicity (ICANS). Additional assessments include immunological effects such as B-cell aplasia and hypogammaglobulinemia, along with in vivo persistence and expansion of the infused CAR-T cells.

Eligible patients will be adults aged 18 years or older with an ECOG performance status of 0-2, an expected life expectancy of at least 12 weeks, and who meet disease-specific eligibility criteria for the relevant subgroup. Patients must have adequate organ function, provide written informed consent, and use appropriate contraception methods. Additional inclusion criteria are defined for high-grade lymphoma, low-grade lymphoma, and B-ALL subgroups. Key exclusion criteria include active infection, uncontrolled cardiac disease, active central nervous system involvement (in relevant subgroups), HIV positivity, active hepatitis infection, pregnancy, severe immunodeficiency, and any condition deemed unsuitable by the investigator.

The treatment process includes leukapheresis for cell collection, administration of lymphodepleting chemotherapy if required, followed by a single infusion of CD19 CAR-T cells. Patients will be closely monitored during the early post-infusion period, particularly within the first 10 days for signs of cytokine release syndrome. Short- and long-term follow-up assessments will include clinical response evaluation, imaging (PET/CT and Lugano criteria for lymphoma), bone marrow evaluation and minimal residual disease analysis (for B-ALL), immunological testing, and transgene detection (qPCR) to monitor CAR-T cell persistence.

The primary endpoint is the overall response rate at Day 28 following infusion. Secondary endpoints include response rates at Days 90 and 180, complete remission rate, survival analyses, relapse rate, evaluation of CRS and other adverse events, and analysis of cellular and immunological parameters.

A total of 40 patients are planned to be enrolled. The overall study duration is expected to be 30 months, including 6 months for patient recruitment, 3 months for infusion and short-term follow-up, and 21 months for long-term follow-up. Statistical analyses will include descriptive statistics, appropriate parametric and non-parametric tests, correlation analyses, and Kaplan-Meier survival analysis. A p-value of <0.05 will be considered statistically significant.

Being tested
Talikabtagene Autoleucel
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
Medical subject headings
Burkitt Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Recurrence, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Talikabtagene AutoleucelBiological

    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.

Study groups in NCT07502118
Study groupRoleWhat they receive
Single Arm - Open Label StudyExperimentalTalikabtagene Autoleucel (NexCAR19) CAR-T Cell Therapy
Receives: Biological: Talikabtagene Autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 28 post-infusion

Secondary outcomes (11)

  1. Complete Remission (CR) Rate

    The proportion of participants achieving complete remission following CAR-T cell infusion.

    For participants with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), response will be assessed by morphological bone marrow evaluation and minimal residual disease (MRD) assessment using flow cytometry.

    For participants with relapsed/refractory B-cell lymphoma, response will be assessed by PET/CT according to the Lugano classification criteria.

    Unit of Measure:

    Percentage of participants

    Measured: Day 90 and Day 180 after CAR-T cell infusion

  2. Overall Response Rate (ORR)

    The proportion of participants achieving an overall response following CAR-T cell infusion. ORR includes complete response (CR), complete response with incomplete hematologic recovery (CRi), and partial response (PR).

    For participants with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), response will be assessed by morphological bone marrow evaluation and minimal residual disease (MRD) assessment using flow cytometry.

    For participants with relapsed/refractory B-cell lymphoma, response will be assessed by PET/CT according to the Lugano classification criteria.

    Unit of Measure:

    Percentage of participants

    Measured: Day 90 and Day 180 after CAR-T cell infusion

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

    Evaluation of serum cytokine profile within the first 10 days following CAR-T infusion to assess its association with the development of CRS.

    Measured: Within 10 days post-infusion

  4. Incidence and duration of B-cell lymphopenia and hypogammaglobulinemia

    Assessment of the incidence and duration of B-cell lymphopenia (BCL) and hypogammaglobulinemia, and evaluation of their correlation with maintenance of complete response.

    Measured: Up to 2 years post-infusion

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

    Sustained disease control is defined as the absence of progressive disease and no requirement for additional anti-leukemic or anti-lymphoma therapy. In patients with relapsed/refractory B-ALL, disease status will be assessed by morphological bone marrow evaluation and minimal residual disease (MRD) analysis using flow cytometry. In patients with relapsed/refractory B-cell lymphoma, disease status will be assessed by PET/CT according to Lugano criteria. The reported value will be the proportion of participants maintaining disease control at each time point.

    Unit of Measure:

    Percentage of participants

    Measured: 1 year and 2 years post-infusion

  6. Persistence of CAR-T Cells in Peripheral Blood Assessed by Transgene Copy Number Using Quantitative Real-Time PCR (qPCR)

    Description In vivo persistence of infused CAR-T cells will be quantified in peripheral blood using transgene detection by quantitative real-time PCR (qPCR). Results will be reported as the number of transgene copies per µg of genomic DNA and summarized longitudinally for each participant.

    Unit of Measure Transgene copies per µg genomic DNA

    Measured: Up to 2 years post-infusion

  7. Expansion of CAR-Expressing T Cells in Peripheral Blood Assessed by Flow Cytometry

    Description Expansion of infused CAR-T cells will be evaluated in peripheral blood using flow cytometry. Results will be reported as the percentage of CAR-positive (CAR+) T cells among the total T-cell population.

    Unit of Measure Percentage of CAR+ T cells

    Measured: Up to 2 years post-infusion

  8. Overall Survival (OS) at Year 1 and Year 2 post CAR-T infusion

    OS is defined as the time from study enrollment to death from any cause. Participants alive at the time of analysis will be censored. Reported values will be the proportion of participants surviving at each time point.

    Unit of Measure: Percentage of participants

    Measured: 1 year and 2 years post-infusion

  9. Event-Free Survival (EFS) at Year 1 and Year 2 post CAR-T infusion

    EFS is defined as the time from study enrollment to the earliest occurrence of disease progression, death, or initiation of new therapy. Reported values will be the proportion of participants event-free at each time point.

    Unit of Measure: Percentage of participants

    Measured: 1 year and 2 years post-infusion

  10. Progression-Free Survival (PFS) at Year 1 and Year 2 post CAR-T infusion

    PFS is defined as the time from study enrollment to disease progression, relapse, or death from any cause. Disease progression will be assessed by PET/CT for lymphoma or bone marrow morphology for B-ALL. Reported values will be the proportion of participants progression-free at each time point.

    Unit of Measure: Percentage of participants

    Measured: 1 year and 2 years post-infusion

  11. Relapse-Free Survival (RFS) at Year 1 and Year 2 post CAR-T infusion

    RFS is defined as the time from study enrollment to disease relapse or death from any cause. Reported values will be the proportion of participants relapse-free at each time point.

    Unit of Measure: Percentage of participants

    Measured: 1 year and 2 years post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start11 Sep 2025
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07502118
Sponsor's protocol ID
TSB-NexCar19
Acronym
NexCAR19
Status last verified
Mar 2026
First submitted
23 Feb 2026
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhu F, Shah N, Xu H, Schneider D, Orentas R, Dropulic B, Hari P, Keever-Taylor CA. Closed-system manufacturing of CD19 and dual-targeted CD20/19 chimeric antigen receptor T cells using the CliniMACS Prodigy device at an academic medical center. Cytotherapy. 2018 Mar;20(3):394-406. doi: 10.1016/j.jcyt.2017.09.005. Epub 2017 Dec 26.

    PubMed 29287970

  • Zhou Y, You MJ, Young KH, Lin P, Lu G, Medeiros LJ, Bueso-Ramos CE. Advances in the molecular pathobiology of B-lymphoblastic leukemia. Hum Pathol. 2012 Sep;43(9):1347-62. doi: 10.1016/j.humpath.2012.02.004. Epub 2012 May 8.

    PubMed 22575265

  • Vairy S, Garcia JL, Teira P, Bittencourt H. CTL019 (tisagenlecleucel): CAR-T therapy for relapsed and refractory B-cell acute lymphoblastic leukemia. Drug Des Devel Ther. 2018 Nov 12;12:3885-3898. doi: 10.2147/DDDT.S138765. eCollection 2018.

    PubMed 30518999

  • Turtle CJ, Hanafi LA, Berger C, Gooley TA, Cherian S, Hudecek M, Sommermeyer D, Melville K, Pender B, Budiarto TM, Robinson E, Steevens NN, Chaney C, Soma L, Chen X, Yeung C, Wood B, Li D, Cao J, Heimfeld S, Jensen MC, Riddell SR, Maloney DG. CD19 CAR-T cells of defined CD4+:CD8+ composition in adult B cell ALL patients. J Clin Invest. 2016 Jun 1;126(6):2123-38. doi: 10.1172/JCI85309. Epub 2016 Apr 25.

    PubMed 27111235

  • Toft N, Birgens H, Abrahamsson J, Griskevicius L, Hallbook H, Heyman M, Klausen TW, Jonsson OG, Palk K, Pruunsild K, Quist-Paulsen P, Vaitkeviciene G, Vettenranta K, Asberg A, Frandsen TL, Marquart HV, Madsen HO, Noren-Nystrom U, Schmiegelow K. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia. Leukemia. 2018 Mar;32(3):606-615. doi: 10.1038/leu.2017.265. Epub 2017 Aug 18.

    PubMed 28819280

  • Teras LR, DeSantis CE, Cerhan JR, Morton LM, Jemal A, Flowers CR. 2016 US lymphoid malignancy statistics by World Health Organization subtypes. CA Cancer J Clin. 2016 Nov 12;66(6):443-459. doi: 10.3322/caac.21357. Epub 2016 Sep 12.

    PubMed 27618563

  • Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.

    PubMed 26980727

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Sun W, Malvar J, Sposto R, Verma A, Wilkes JJ, Dennis R, Heym K, Laetsch TW, Widener M, Rheingold SR, Oesterheld J, Hijiya N, Sulis ML, Huynh V, Place AE, Bittencourt H, Hutchinson R, Messinger Y, Chang B, Matloub Y, Ziegler DS, Gardner R, Cooper T, Ceppi F, Hermiston M, Dalla-Pozza L, Schultz KR, Gaynon P, Wayne AS, Whitlock JA. Outcome of children with multiply relapsed B-cell acute lymphoblastic leukemia: a therapeutic advances in childhood leukemia & lymphoma study. Leukemia. 2018 Nov;32(11):2316-2325. doi: 10.1038/s41375-018-0094-0. Epub 2018 Mar 15.

    PubMed 29728694

  • Shankland KR, Armitage JO, Hancock BW. Non-Hodgkin lymphoma. Lancet. 2012 Sep 1;380(9844):848-57. doi: 10.1016/S0140-6736(12)60605-9. Epub 2012 Jul 25.

    PubMed 22835603

  • Shah NN, Lee DW, Yates B, Yuan CM, Shalabi H, Martin S, Wolters PL, Steinberg SM, Baker EH, Delbrook CP, Stetler-Stevenson M, Fry TJ, Stroncek DF, Mackall CL. Long-Term Follow-Up of CD19-CAR T-Cell Therapy in Children and Young Adults With B-ALL. J Clin Oncol. 2021 May 20;39(15):1650-1659. doi: 10.1200/JCO.20.02262. Epub 2021 Mar 25.

    PubMed 33764809

  • Shah NN, Highfill SL, Shalabi H, Yates B, Jin J, Wolters PL, Ombrello A, Steinberg SM, Martin S, Delbrook C, Hoffman L, Little L, Ponduri A, Qin H, Qureshi H, Dulau-Florea A, Salem D, Wang HW, Yuan C, Stetler-Stevenson M, Panch S, Tran M, Mackall CL, Stroncek DF, Fry TJ. CD4/CD8 T-Cell Selection Affects Chimeric Antigen Receptor (CAR) T-Cell Potency and Toxicity: Updated Results From a Phase I Anti-CD22 CAR T-Cell Trial. J Clin Oncol. 2020 Jun 10;38(17):1938-1950. doi: 10.1200/JCO.19.03279. Epub 2020 Apr 14.

    PubMed 32286905

  • Schrappe M, Hunger SP, Pui CH, Saha V, Gaynon PS, Baruchel A, Conter V, Otten J, Ohara A, Versluys AB, Escherich G, Heyman M, Silverman LB, Horibe K, Mann G, Camitta BM, Harbott J, Riehm H, Richards S, Devidas M, Zimmermann M. Outcomes after induction failure in childhood acute lymphoblastic leukemia. N Engl J Med. 2012 Apr 12;366(15):1371-81. doi: 10.1056/NEJMoa1110169.

    PubMed 22494120

  • Roselli E, Faramand R, Davila ML. Insight into next-generation CAR therapeutics: designing CAR T cells to improve clinical outcomes. J Clin Invest. 2021 Jan 19;131(2):e142030. doi: 10.1172/JCI142030.

    PubMed 33463538

  • Pui CH, Yang JJ, Hunger SP, Pieters R, Schrappe M, Biondi A, Vora A, Baruchel A, Silverman LB, Schmiegelow K, Escherich G, Horibe K, Benoit YC, Izraeli S, Yeoh AE, Liang DC, Downing JR, Evans WE, Relling MV, Mullighan CG. Childhood Acute Lymphoblastic Leukemia: Progress Through Collaboration. J Clin Oncol. 2015 Sep 20;33(27):2938-48. doi: 10.1200/JCO.2014.59.1636. Epub 2015 Aug 24.

    PubMed 26304874

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Talikabtagene Autoleucel in people with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and Relapsed/Refractory Non-Hodgkin Lymphoma, run by Health Institutes of Turkey at 4 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 76 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Funda Ceran Ankara Bilkent City Hospital - Hematology Clinic, Prof. MD (+90 (312) 552 60 00, ceranf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) to CD19 CAR-T cell product at Day 28 post-infusion (time frame: Day 28 post-infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07502118, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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