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

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

Inclusion Criteria3

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

Exclusion Criteria14

  • \- 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 Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
  • 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.
  • Individuals with detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or a history of central nervous system (CNS) lymphoma, primary CNS lymphoma, or spinal epidural involvement.
  • 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 2 years.
  • History of non-line associated, clinically significant deep-vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within the 6 months before enrollment.
  • 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.

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(14)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Stanford Cancer Institute

Stanford, California, United States

Northside Hospital

Atlanta, Georgia, 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

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