RecruitingPhase 2NCT04792489

DALY II USA/ 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

248 participants

Start Date

May 25, 2021

Study Type

INTERVENTIONAL

Conditions

Central Nervous System Lymphoma Transformed Lymphoma Mantle Cell Lymphoma (MCL)Relapsed Diffuse Large B Cell Lymphoma Primary Mediastinal B-cell Lymphoma (PMBCL)Refractory Diffuse Large B-cell Lymphoma (DLBCL)Richter Transformation High-grade B-cell Lymphoma (HGBCL)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing MB-CART2019.1, a CAR-T cell therapy — a treatment where a patient's own immune cells are genetically reprogrammed to attack cancer — in people with relapsed or treatment-resistant large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL). Researchers are looking at safety and how well this new therapy works. **You may be eligible if...** - You have a confirmed diagnosis of DLBCL or a related large B-cell lymphoma subtype (including transformed lymphoma) - Your lymphoma has come back or stopped responding to standard treatments - You have received prior lines of therapy - You meet health and fitness criteria to receive cell therapy **You may NOT be eligible if...** - Your lymphoma type is not one of the B-cell subtypes covered by this trial - You have active infections or other conditions that make cell therapy unsafe - You do not meet the general health requirements for this type of treatment 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

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 Center

Gilbert, Arizona, United States

Mayo Clinic

Phoenix, Arizona, United States

UC San Diego Health

La Jolla, California, United States

Stanford University

Stanford, California, United States

Yale University

New Haven, Connecticut, United States

Baptist Health Miami Cancer Institute

Miami, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Robert H Lurie Cancer Center

Chicago, Illinois, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center - Division of Hematologic Malignancies

Durham, North Carolina, United States

The Ohio State University Wexner Medical Center James Cancer

Columbus, Ohio, United States

Oregon Health and Science University Knight Cancer Institute

Portland, Oregon, United States

Allegheny Health Network Cancer Institute

Pittsburgh, Pennsylvania, United States

University of Pittsburgh - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

University of Alberta Cross Cancer Institute

Edmonton, Alberta, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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