RECRUITING

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

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Conditions

Relapsed and/or Refractory B-cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-27
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04989803

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Relapsed and/or refractory B-cell lymphoma (R/R BCL).
  2. * At least 1 measurable lesion.
  3. * Adequate organ and bone marrow (BM) function.
  1. * 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.
  2. * History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
  3. * History of allogeneic stem cell transplant (allo-SCT).
  4. * Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.
  5. * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
  6. * 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.
  7. * 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.
  8. * History or presence of a CNS disorder.
  9. * 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.
  10. * Primary immunodeficiency.
  11. * History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 2 years.
  12. * History of non-line associated, clinically significant deep-vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within the 6 months before enrollment.
  13. * 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.

Contacts and Locations

Study Contact

Medical Information
CONTACT
844-454-5483(1-844-454-KITE)
medinfo@kitepharma.com

Principal Investigator

Kite Study Director
STUDY_DIRECTOR
Kite, A Gilead Company

Study Locations (Sites)

Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Stanford Cancer Institute
Stanford, California, 94305
United States
Northside Hospital
Atlanta, Georgia, 30342
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
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502
United States

Collaborators and Investigators

Sponsor: Kite, A Gilead Company

  • Kite Study Director, STUDY_DIRECTOR, Kite, A Gilead Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-27
Study Completion Date2027-10

Study Record Updates

Study Start Date2021-10-27
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsed and/or Refractory B-cell Lymphoma