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DALY II USA/ MB-CART2019.1 for DLBCL

NCT04792489 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2026-07-13

No results posted yet for this study

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.

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
  • Transplant-ineligible 2nd Line DLBCL

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

Sponsors & Collaborators

  • Miltenyi Biomedicine GmbH

    lead INDUSTRY

Principal Investigators

  • Johanna Theruvath, MD · Miltenyi Biomedicine GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04792489 on ClinicalTrials.gov