OncoMatch/Clinical Trials/NCT04792489
DALY II USA/ MB-CART2019.1 for DLBCL
Is NCT04792489 recruiting? Yes, currently enrolling (Sep 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 B cell lymphoma (BCL). Cohorts include subjects with diffuse large B-cell lymphoma (DLBCL) after receiving at least 2 lines of therapy, primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL) after receiving at least one line of therapy, mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy, and DLBCL transplant-ineligible after receiving at least one line of therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Primary Central Nervous System Lymphoma
Biomarker criteria
Required: MYC rearrangement
High-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: BCL2 rearrangement
High-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: BCL6 rearrangement
High-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: CCND1 overexpression
MCL determined by overexpression of cyclin D1
Required: CCND1 t(11;14)(q13;q32) translocation
presence of t(11;14) (q13; q32) translocation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic chemotherapy including rituximab or equivalent and anthracycline — DLBCL (and associated subtypes), after failure of 2 or more lines
persistent disease after failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either after failed ASCT, or ineligible, not intended for or not consenting to ASCT
Must have received: systemic therapy — CNS cohort: PCNSL, at least first-line therapy
Subjects with relapsed/refractory PCNSL that have failed (or unable to tolerate) at least first-line therapy
Must have received: systemic therapy including anti-CD20 monoclonal antibody and anthracycline — CNS cohort: SCNSL, at least one prior line
Subjects with SCNSL must have relapsed or refractory disease after having received at least one prior line of systemic therapy. Prior lines of systemic therapy should include an anti-CD20 monoclonal antibody and anthracycline containing chemotherapy regimen and/or with or without an autologous stem cell transplant
Must have received: cytotoxic rituximab-based chemotherapy AND BTK inhibitor — MCL cohort: relapsed/refractory after at least one prior systemic treatment
MCL cohort: Subjects with relapsed/refractory disease after at least one prior systemic treatment, that must include: Cytotoxic rituximab [or equivalent] based chemotherapy regimen (eg, rituximab bendamustine, R-CHOP, R-DHAP, R-ARA-C) AND BTK inhibitor
Must have received: systemic therapy — RT cohort: relapsed/refractory after at least one prior systemic treatment following Richter's Transformation
RT cohort: Subject must have relapsed/refractory disease after at least one prior systemic treatment following Richter's Transformation
Must have received: systemic chemotherapy including rituximab or equivalent and anthracycline — DLBCL transplant ineligible 2nd cohort: failure of first-line chemotherapy
DLBCL transplant ineligible 2nd cohort: subject must have failure of first-line chemotherapy (including rituximab or equivalent and anthracycline)
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 for B-cell lymphoma
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 T cell engaging (BITE) antibodies
Prior Bispecific T cell engaging (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
ANC >1000/μL; absolute lymphocyte count >100/μL; platelet count >50,000/μL
Kidney function
Creatinine clearance >45 mL/min; DLBCL transplant-ineligible 2nd-line cohort: calculated creatinine clearance <60 mL/min is ineligible
Liver function
AST/ALT <5x ULN for age; total bilirubin <1.5 mg/dL (except Gilbert's syndrome); DLBCL transplant-ineligible 2nd-line cohort: total bilirubin <2.0 mg/dL allowed; AST/ALT >2x ULN is exclusion for transplant-ineligible cohort
Cardiac function
Ejection fraction (EF) ≥45% (ECHO or MUGA); DLBCL transplant-ineligible 2nd-line cohort: EF >40% allowed; LVEF <50% is ineligible for transplant-ineligible cohort
Impaired pulmonary function: DLCO ≤60% (transplant-ineligible); Impaired cardiac function: LVEF <50% (transplant-ineligible); Impaired renal function: creatinine clearance <60 mL/min (transplant-ineligible); AST/ALT >2x ULN (transplant-ineligible); Serum ALT/AST <5x ULN for age; total bilirubin <1.5 mg/dL (except Gilbert's syndrome); DLBCL transplant-ineligible 2nd-line cohort: total bilirubin <2.0 mg/dL allowed; ANC >1000/μL; absolute lymphocyte count >100/μL; platelet count >50,000/μL; EF ≥45% (ECHO or MUGA); DLBCL transplant-ineligible 2nd-line cohort: EF >40% allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Mayo Clinic · Phoenix, Arizona
- UC San Diego Health · La Jolla, California
- Stanford University · Stanford, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04792489 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, systemic gene modifying therapy for B-cell lymphoma, allogeneic stem cell transplant disqualifies patients from enrollment.
Does this trial require MYC?
Yes, MYC rearrangement is a required biomarker for enrollment.
Does this trial require BCL2?
Yes, BCL2 rearrangement is a required biomarker for enrollment.
Does this trial require BCL6?
Yes, BCL6 rearrangement is a required biomarker for 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