ACTIVE_NOT_RECRUITING

Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma

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Conditions

Relapsed/Refractory Large 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

This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical study is learn about the effectiveness of the recommended dose of KITE-197 in participants with r/r LBCL. The primary objectives of this study are: Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the target dose level for Phase 1b. Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by the complete remission (CR) rate.

Official Title

A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma

Quick Facts

Study Start:2023-11-09
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06079164

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 or Refractory Large B-cell Lymphoma
  2. * At least 1 measurable lesion
  3. * Adequate organ and bone marrow function
  1. * History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 2 years
  2. * History of Richter's transformation of chronic leukemic lymphoma
  3. * History of allogenic stem cell transplant (SCT)
  4. * Autologous SCT within 6 weeks of planned KITE-197 infusion
  5. * Prior CD19 targeted antibody, such as tafasitamab and loncastuximab with the exception of individuals who have previously achieved an objective response to such therapy and their tumor expresses CD19 by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (IHC) at the time of screening. Individuals who meet these criteria may be eligible
  6. * Prior treatment with bendamustine within 6 months of enrollment
  7. * Prior CAR therapy or other genetically modified cell therapy
  8. * Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management
  9. * History of HIV infection or acute or chronic active hepatitis B or C infection
  10. * History or presence of a clinically significant central nervous system (CNS) disorder Note: Prior or active CNS involvement by lymphoma is not an exclusion criterion.
  11. * History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months before enrollment
  12. * Presence of primary immunodeficiency
  13. * History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
  14. * History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3 months before enrollment. Catheter induced DVT which has been treated for at least 6 weeks prior to enrollment is permitted
  15. * Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant

Contacts and Locations

Principal Investigator

Kite Study Director
STUDY_DIRECTOR
Kite, A Gilead Company

Study Locations (Sites)

Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
United States
St. David's South Austin Medical Center
Austin, Texas, 78704
United States
Swedish Cancer Institute
Seattle, Washington, 98104
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 Date2023-11-09
Study Completion Date2028-01

Study Record Updates

Study Start Date2023-11-09
Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsed/Refractory Large B-cell Lymphoma