OncoMatch/Clinical Trials/NCT07288879
DALY II Japan/MB-CART2019.1 for DLBCL
Is NCT07288879 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT07288879 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, allogeneic stem cell transplant, bispecific antibody disqualifies patients from enrollment.
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