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
Miltenyi Biomedicine GmbH
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.
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 produ…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed B-cell non-Hodgkin's lymphoma: * DLBCL DLBCL or associated subtype, defined by WHO 2016 classification: * DLBCL not otherwise specified (NOS) * High-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements * High-grade B cell lymphoma (NOS) * Primary mediastinal (thymic) large B cell lymphoma * Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3) * CNS Cohort only: B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL) * Mantle Cell Lymphoma (MCL) Cohort: H…
Interventions
- Biologicalzamtocabtagene autoleucel (MB-CART2019.1)
Chimeric antigen receptor (CAR) T cell therapy
- DrugCyclophosphamide
Lymphodepleting chemotherapy
- DrugFludarabine
Lymphodepleting chemotherapy
- DrugBendamustine
Lymphodepleting chemotherapy
Locations (25)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Mayo ClinicPhoenix, Arizona
- UC San Diego HealthLa Jolla, California
- Stanford UniversityStanford, California
- Yale UniversityNew Haven, Connecticut
- Baptist Health Miami Cancer InstituteMiami, Florida