OncoMatch/Clinical Trials/NCT06508931
Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms
Is NCT06508931 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies zamtocabtagene autoleucel (MB-CART2019.1) for b-cell neoplasm.
Treatment: zamtocabtagene autoleucel (MB-CART2019.1) — This is a single-arm, multi-center, open-label Phase II study to determine the safety and efficacy of MB-CART2019.1 in pediatric and adolescent subjects (aged between 6 months and \<18 years, ≥6 kg body weight \[BW\]) with mature B-cell neoplasms and aggressive lymphomas that relapsed after or are refractory to one or more prior therapies, including subjects with primary refractory disease.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CD19 overexpression (CD19+)
Has histologically confirmed mature CD19+ and/or CD20+ B-cell neoplasm
Required: CD20 overexpression (CD20+)
Has histologically confirmed mature CD19+ and/or CD20+ B-cell neoplasm
Prior therapy
Must have received: any prior therapy
Has r/r B-cell neoplasms after one or more prior therapies or primary refractory to first-line therapy.
Cannot have received: allogeneic HSCT
Had allogeneic HSCT.
Cannot have received: autologous HSCT
Exception: if <120 days prior to written informed consent
Had autologous HSCT <120 days prior to written informed consent.
Cannot have received: anti-CD19 CAR-T cell therapy
Exception: if <100 days prior to informed consent/assent
Has been previously treated with approved anti-CD19 or anti-CD20 CART cell therapies <100 days prior to informed consent/assent.
Cannot have received: anti-CD20 CAR-T cell therapy
Exception: if <100 days prior to informed consent/assent
Has been previously treated with approved anti-CD19 or anti-CD20 CART cell therapies <100 days prior to informed consent/assent.
Lab requirements
Blood counts
ANC >1000/μL; Platelets ≥50000/μL; Hemoglobin ≥8.0 g/dL; Absolute lymphocyte count ≥100/μL
Kidney function
eGFR >29 mL/min by Schwartz formula
Liver function
AST and ALT ≤5 × ULN for age; Bilirubin <1.5 x ULN (for Gilbert's Syndrome, subject's total bilirubin <4 mg/dL)
Cardiac function
Fractional shortening <28% or left ventricular ejection fraction <50% by echocardiography or multigated acquisition, if allowed as per local law [excluded]
Has adequate bone marrow function as defined by the following laboratory values... Has adequate organ function as follows: Renal function: eGFR >29 mL/min by Schwartz formula; AST and ALT ≤5 × ULN for age; Bilirubin <1.5 x ULN (for Gilbert's Syndrome, subject's total bilirubin <4 mg/dL); Adequate pulmonary function as follows: Resting oxygen saturation of ≥91% on room air; No or mild dyspnea (Grade ≤1). Has impaired cardiac function: Fractional shortening <28% or left ventricular ejection fraction <50% by echocardiography or multigated acquisition, if allowed as per local law [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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