Recruiting PHASE2, PHASE3 Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)

New treatment option for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)

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

ClinicalTrials.gov ID: NCT07502118

What this study is testing

What is Talikabtagene Autoleucel?

Talikabtagene Autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory b-cell acute lymphoblastic leukemia (b-all).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

All participants must meet 1-13. Additionally:
High-grade lymphoma people must meet Criteria 14-18.
Other B-cell lymphoma people must meet Criteria 19-24.
B-ALL people must meet Criteria 25-29. General (Applicable to All Cohorts)
Age ≥18 years.

You likely can't join 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.

See the full eligibility criteria

Who can join

All participants must meet 1-13. Additionally:
High-grade lymphoma people must meet Criteria 14-18.
Other B-cell lymphoma people must meet Criteria 19-24.
B-ALL people must meet Criteria 25-29. General (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...
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 (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 people must have received ≥2 prior systemic lines.
Measurable disease per International Working Group (IWG) criteria. Other B-Cell Lymphomas - Additional (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 (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

What rules you out

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.
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...
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...

The study team makes the final eligibility decision.

Where it's taking place

Ankara, Turkey (Türkiye)

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Ankara, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.