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 (Jun 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
Treatments studied
Other
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
Demographics
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.
Frequently asked questions
Is NCT06508931 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic HSCT, autologous HSCT, anti-CD19 CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Does this trial require CD20?
Yes, CD20 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 17 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify