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

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• 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

Locations (32)