NCT04792489

DALY II USA/ MB-CART2019.1 for DLBCL

A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and/or Refractory Diffuse Large B Cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Miltenyi Biomedicine GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.

Detailed description

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. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy. 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.

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

Interventions

Type	Name	Description
BIOLOGICAL	zamtocabtagene autoleucel (MB-CART2019.1)	Chimeric antigen receptor (CAR) T cell therapy
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy
DRUG	Fludarabine	Lymphodepleting chemotherapy
DRUG	Bendamustine	Lymphodepleting chemotherapy

Timeline

• Start date: 2021-05-25
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2021-03-11
• Last updated: 2025-04-24

Locations

25 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study