OncoMatch/Clinical Trials/NCT07288879
DALY II Japan/MB-CART2019.1 for DLBCL
Is NCT07288879 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies MB-CART2019.1 for dlbcl - diffuse large b cell lymphoma.
Treatment: MB-CART2019.1 — DALY II Japan 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: MYC rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Allowed: BCL2 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Allowed: BCL6 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Allowed: CD19 expression
CD19 or CD20 antigen expression on tumor is not required after the most recent chemoimmunotherapy
Allowed: CD20 expression
CD19 or CD20 antigen expression on tumor is not required after the most recent chemoimmunotherapy
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy (rituximab, anthracycline)
Relapsed or refractory disease after 2 or more lines of chemotherapy including rituximab and anthracycline
Must have received: autologous stem cell transplant
either having failed autologous stem cell transplant (ASCT), or being ineligible for or not consenting to ASCT
Cannot have received: CAR-T cell therapy
Prior CAR T cell therapy for any indication
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant for any indication
Cannot have received: bispecific antibody
Prior bispecific antibodies for cancer therapy
Cannot have received: T cell receptor-engineered T cell therapy
Prior T cell receptor-engineered T cell therapy
Cannot have received: anti-CD19 immunotherapy
Prior anti CD 19 immunotherapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) > 1000/μL; Absolute lymphocyte count > 100/μL; Platelet count > 50,000/μL
Kidney function
Estimated creatinine clearance by Cockcroft-Gault Equation (eGFR) > 60mL/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)
ALT/AST <5x ULN; Total bilirubin <1.5 mg/dl, except Gilbert's; eGFR > 60mL/min; ANC > 1000/μL; lymphocyte count > 100/μL; platelets > 50,000/μL; EF ≥ 45%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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