RecruitingPhase 1Phase 2NCT04989803

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-cell Therapies, in Subjects With Relapsed and/or Refractory B-cell Lymphoma

Sponsor

Kite, A Gilead Company

Enrollment

247 participants

Start Date

Oct 27, 2021

Study Type

INTERVENTIONAL

Conditions

Relapsed and/or Refractory B-cell Lymphoma

Summary

The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two new experimental cell therapy treatments (KITE-363 and KITE-753) in patients with B-cell lymphoma that has come back or stopped responding to prior treatments. These are engineered immune cell therapies designed to attack lymphoma cells. **You may be eligible if...** - You have relapsed or refractory B-cell lymphoma (cancer came back or stopped responding) - You have at least one measurable area of disease - Your organs and bone marrow are functioning adequately **You may NOT be eligible if...** - You have had previous CAR-T cell therapy or other genetically modified T-cell treatments - You have had an allogeneic (donor) stem cell transplant - You have a currently active or uncontrolled infection - You have a history of HIV, active hepatitis B or C - You have brain involvement from lymphoma - You have had significant heart problems in the past 6 months - You have a history of serious autoimmune disease requiring immune-suppressing medications in the last 2 years - You are pregnant or breastfeeding 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

DRUGCyclophosphamide

Lymphodepleting chemotherapy administered intravenously

DRUGFludarabine

Lymphodepleting chemotherapy administered intravenously

BIOLOGICALKITE-363

A single infusion of CAR-transduced autologous T cells administered intravenously

BIOLOGICALKITE-753

A single infusion of CAR-transduced autologous T cells administered intravenously

Locations(18)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

Stanford Cancer Institute

Stanford, California, United States

Northside Hospital

Atlanta, Georgia, United States

Midwestern Regional Medical Center, Inc.City of Hope Chicago

Park Ridge, Illinois, United States

University of MD, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Columbia University Irving Medical Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Concord Repatriation General Hospital

Sydney, New South Wales, Australia

Epworth Healthcare

East Melbourne, Victoria, Australia

Universitatsklinikum Wurzburg

Würzburg, Germany

Academisch Medisch Centrum

Amsterdam, Netherlands

King's College Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04989803