RecruitingPhase 2NCT07288879

DALY II Japan/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.


Sponsor

Miltenyi Biomedicine GmbH

Enrollment

31 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

DALY II Japan 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a CAR-T cell therapy called MB-CART2019.1 — a treatment using your own genetically engineered immune cells to attack cancer — in people with diffuse large B-cell lymphoma (DLBCL) and related aggressive lymphomas that have come back or stopped responding to multiple prior treatments. **You may be eligible if...** - You have a confirmed diagnosis of DLBCL or a related aggressive B-cell lymphoma subtype - Your lymphoma has relapsed or is no longer responding after at least 2 lines of chemotherapy including rituximab and an anthracycline drug - You have either already had and failed a stem cell transplant, or are not eligible for one - You have at least one measurable lesion on imaging **You may NOT be eligible if...** - You have not yet tried at least 2 prior treatment regimens - You have active brain involvement from lymphoma - Your organ function is significantly impaired - You have an active serious infection or another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMB-CART2019.1

CAR T cell therapy


Locations(5)

National Cancer Center Hospital

Tokyo, Japan

Toranomon Hospital

Tokyo, Japan

Juntendo University Hospital

Tokyo, Japan

Tokyo Metropolitan Komagome Hospital

Tokyo, Japan

Keio University Hospital

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07288879


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