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NCT04989803PHASE1, PHASE2Recruiting

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

Kite, A Gilead Company

Start Date

10/27/2021

Completion Date

2/1/2030

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.

Detailed Description

Eligible study participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: for Phase 1a/b and Phase 2 * Relapsed and/or refractory B-cell lymphoma (R/R BCL). * At least 1 measurable lesion. * Adequate organ and bone marrow (BM) function. Key Exclusion Criteria: for Phase 1a/b and Phase 2 \- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy. * History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years. * History of allogeneic stem cell transplant (allo-SCT). * Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion. * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management. * Known history of human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) (hepatitis B surface \[HBs\] antigen \[HBsAg\] positive) infection, or hepatitis C (anti-hepatitis C virus \[HCV\] positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing. * Individuals with suspicion and/or evidence of primary or secondary CNS lymphoma. * History or presence of a CNS disorder. * History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment. * Primary immunodeficiency. * History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 90 days. * Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and/or transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation. * Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Cyclophosphamide

DRUG

Fludarabine

BIOLOGICAL

KITE-363

BIOLOGICAL

KITE-753

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Conditions

Relapsed and/or Refractory B-cell Lymphoma

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

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

Duarte, California 91010

United States

Stanford Cancer Institute

Stanford, California 94305

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Northside Hospital

Atlanta, Georgia 30342

United States

Midwestern Regional Medical Center, Inc.City of Hope Chicago

Park Ridge, Illinois 60068

United States

Norton Cancer Institute, St. Matthews Campus

Shelbyville, Kentucky 40065

United States

University of MD, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio 43210

United States

Tennessee Oncology, PLLC - Investigational Drug Services

Nashville, Tennessee 37203

United States

Vanderbilt University

Nashville, Tennessee 37232

United States

St. David's Medical Center

Austin, Texas 78704

United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas 77030

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Royal North Shore Hospital

St Leonards, New South Wales 2065

Australia

Concord Repatriation General Hospital

Sydney, New South Wales 2139

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Epworth Healthcare

East Melbourne, Victoria 3002

Australia

Jewish General Hospital

Montreal, H3T 1E2

Canada

McGill University Health Center

Montreal, H4A 0B1

Canada

Universitatsklinikum Wurzburg

Würzburg, 97080

Germany

Academisch Medisch Centrum

Amsterdam, 1105 AZ

Netherlands

King's College Hospital

London, SE5 9RS

United Kingdom