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

Description

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

Conditions

Relapsed and/or Refractory B-cell Lymphoma

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Study Overview

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Study Details

Study overview

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

A Phase 1 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

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

Condition
Relapsed and/or Refractory B-cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Stanford

Stanford Cancer Institute, Stanford, California, United States, 94305

Atlanta

Northside Hospital, Atlanta, Georgia, United States, 30342

Baltimore

University of MD, Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States, 21201

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Rochester

University of Rochester Medical Center, Rochester, New York, United States, 14642

Columbus

The Ohio State University Wexner Medical Center - James Cancer Hospital, Columbus, Ohio, United States, 43210

Houston

The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kite, A Gilead Company,

Kite Study Director, STUDY_DIRECTOR, Kite, A Gilead Company

Study Record Dates

2026-07