DALY II USA/ MB-CART2019.1 for DLBCL

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT04792489
Trial Phases:	Phase II	Protocol IDs:	M-2018-344 (primary) NCI-2021-08357
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Miltenyi Biomedicine GmbH
NCI Full Details:	http://clinicaltrials.gov/show/NCT04792489

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 diffuse large B cell lymphoma (DLBCL) after receiving at
least two lines of therapy.

Objectives

A prospective, single arm, open label, multi-center, phase II study of autologous T cells
engineered against both CD19 and CD20 antigens for subjects with relapsed or refractory
DLBCL after receiving at least two lines of therapy. The investigational agent is the
MB-CART2019.1 cells. After successful screening, subjects will undergo leukapheresis to
collect product for manufacturing. In preparation for the fresh product infusion,
subjects will undergo a lymphodepleting regimen with cyclophosphamide and fludarabine, or
bendamustine. Cell infusion will be administered intravenously at a dose of 2.5 x 106
CAR+ cells/kg body weight. The study will start with enrollment of 3 subjects in the
lead-in safety phase, and after safety is evaluated, the study will continue with
enrollment of the remaining subjects. Subjects will be followed for up to 2 years, for
efficacy and safety outcomes as well as health-related quality of life (HRQol).
Additional long-term follow-up will be conducted for participants under a separate
long-term follow-up protocol.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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