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
Kite, A Gilead Company
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.
Description
Eligible study participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: for Phase 1a/b and Phase 2 * Relapsed and/or refractory B-cell lymphoma (R/R BCL). * At least 1 measurable lesion. * Adequate organ and bone marrow (BM) function. Key Exclusion Criteria: for Phase 1a/b and Phase 2 \- 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. *…
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 (18)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, California
- Stanford Cancer InstituteStanford, California
- Northside HospitalAtlanta, Georgia
- Midwestern Regional Medical Center, Inc.City of Hope ChicagoPark Ridge, Illinois
- University of MD, Greenebaum Comprehensive Cancer CenterBaltimore, Maryland