Study Details

OVERVIEW

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 (PALISADES-1)

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Relapsed and/or Refractory B-cell Lymphoma

Gender

N/A

Date

October 2021 - February 2030

Study Type

INTERVENTIONAL

Study Phase

PHASE1, PHASE2

Product

Cyclophosphamide, Fludarabine, KITE-363, KITE-753

Eligibility Information

Inclusion Criteria

Relapsed and/or refractory B-cell lymphoma (R/R BCL).
At least 1 measurable lesion.
Adequate organ and bone marrow (BM) function.

Exclusion Criteria

\- 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.

Locations

Locations (18)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

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

Duarte, California, United States, 91010

Stanford Cancer Institute

Stanford, California, United States, 94305

Northside Hospital

Atlanta, Georgia, United States, 30342

Midwestern Regional Medical Center, Inc.City of Hope Chicago

Park Ridge, Illinois, United States, 60068

University of MD, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Columbia University Irving Medical Center

New York, New York, United States, 10032

University of Rochester Medical Center

Rochester, New York, United States, 14642

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, United States, 43210

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States, 77030

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

Concord Repatriation General Hospital

Sydney, New South Wales, Australia, 2139

Epworth Healthcare

East Melbourne, Victoria, Australia, 3002

Universitatsklinikum Wurzburg

Würzburg, Germany, 97080

Academisch Medisch Centrum

Amsterdam, Netherlands, 1105 AZ

King's College Hospital

London, United Kingdom, SE5 9RS

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (PALISADES-1)