OncoMatch/Clinical Trials/NCT04792489
DALY II USA/ MB-CART2019.1 for DLBCL
Is NCT04792489 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including zamtocabtagene autoleucel (MB-CART2019.1) and Cyclophosphamide for refractory diffuse large b cell lymphoma (dlbcl).
Treatment: zamtocabtagene autoleucel (MB-CART2019.1) · Cyclophosphamide · Fludarabine · Bendamustine — DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
Required: CCND1 t(11;14) (q13; q32) translocation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cytotoxic chemotherapy (rituximab)
failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline
Must have received: anthracycline
failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline
Must have received: autologous stem cell transplant
either having failed autologous stem cell transplant (ASCT), or ineligible, not intended for or not consenting to ASCT
Must have received: BTK inhibitor — MCL cohort
MCL Cohort: Subjects with relapsed/refractory disease after at least one prior systemic treatment, that must include: Cytotoxic rituximab-based chemotherapy regimen ... AND BTK inhibitor
Cannot have received: CAR-T cell therapy
Prior CAR-T therapy for any indication or systemic gene modifying therapy for B-cell lymphoma
Cannot have received: systemic gene modifying therapy
Prior CAR-T therapy for any indication or systemic gene modifying therapy for B-cell lymphoma
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant for any indication
Cannot have received: bispecific antibody
Prior BITE antibodies for cancer therapy
Cannot have received: T cell receptor-engineered T cell therapy
Prior T cell receptor-engineered T cell therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) > 1000/μL; Absolute lymphocyte count > 100/μL; Platelet count > 50,000/µL
Kidney function
A creatinine clearance (as estimated by direct urine collection or Cockcroft-Gault Equation) > 45mL/min
Liver function
Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST)<5 times the Upper Limit of Normal (ULN) for age; Total bilirubin <1.5 mg/dl, except in individuals with Gilbert's syndrome
Cardiac function
Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA)
A creatinine clearance ... > 45mL/min; Cardiac ejection fraction (EF) ≥ 45% ...; Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST)<5 times the Upper Limit of Normal (ULN) for age; Total bilirubin <1.5 mg/dl, except in individuals with Gilbert's syndrome; Absolute neutrophil count (ANC) > 1000/μL; Absolute lymphocyte count > 100/μL; Platelet count > 50,000/µL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Mayo Clinic · Phoenix, Arizona
- UC San Diego Health · La Jolla, California
- Stanford University · Stanford, California
- Yale University · New Haven, Connecticut
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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