Clinical Trial

DALY II USA/ MB-CART2019.1 for DLBCL

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2021-03-09; most recent amendment 2026-07-09.
Status change: Not Yet Recruiting → Recruiting 2021-05-27
Trial Details
NCT Number NCT04792489
Lead Sponsor Miltenyi Biomedicine GmbH
Conditions Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma, High Grade B-cell Lymphoma (HGBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), Transformed Lymphoma, Central Nervous System Lymphoma, Mantle Cell Lymphoma (MCL), Richter Transformation +1 more
Enrollment 315 participants
Start Date 2021-05-25
Primary Completion 2026-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-13