drugset / Trial / NCT04792489

DALY II USA/ MB-CART2019.1 for DLBCL

NCT04792489

Phase 2 Recruiting 315 enrolled Miltenyi Biomedicine GmbH
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-05-25
Primary completion
2026-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject zamtocabtagene autoleucel Cell therapy 2.5e+06 cells/kg Intravenous
Background Bendamustine Small molecule
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule