CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 248 target
Drug / intervention
zamtocabtagene autoleucel (MB-CART2019.1) +3 morebiological
Likely dose
Not stated in record
Key inclusion· 25
  • Histologically confirmed B-cell non-Hodgkin's lymphoma
  • DLBCL (NOS or associated subtypes per WHO 2016)
  • High-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
  • Primary mediastinal (thymic) large B cell lymphoma
Key exclusion· 22
  • Primary CNS lymphoma (not applicable to CNS cohort)
  • Richter's transformed DLBCL from CLL (not applicable to RT cohort)
  • Unable to give informed consent
  • Known history of HIV or active hepatitis B (HBsAg positive)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04792489
NCT04792489Phase 2RecruitingHigh MomentumUpdated 14mo ago
Long Recruiting

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·interventional·Posted Mar 11, 2021·Updated Apr 24, 2025

In Brief

A Phase 2 clinical trial evaluating zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide, and 2 other interventions for Refractory Diffuse Large B Cell Lymphoma (DLBCL) and 7 related conditions. Currently recruiting, targeting 248 participants across 25 sites in 2 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Timeline

Phase 2Recruiting
202120222023202420252026202720282029
First PostedMar 11, 2021
Enrollment StartMay 25, 2021
Primary CompletionDec 31, 2026
Study CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 5.3 years agoPrimary completion in 6 months

Interventions

zamtocabtagene autoleucel (MB-CART2019.1)biological

Chimeric antigen receptor (CAR) T cell therapy

Cyclophosphamidedrug

Lymphodepleting chemotherapy

Fludarabinedrug

Lymphodepleting chemotherapy

Bendamustinedrug

Lymphodepleting chemotherapy