Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Stopped early · Phase 1
Conditions studied: Relapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma
In brief
The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL) who have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor. After the end of KTE-C19-108, participants who received an infusion of brexucabtagene autoleucel will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968 (NCT05041309).
Key facts
- Study ID
- NCT03624036
- Run by
- Kite, A Gilead Company
- People needed
- 16
- Starts
- 2018-11-15
- Expected to finish
- 2022-11-18
- Last updated by the study team
- 2023-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic - Arizona — Phoenix, Arizona, United States
- University of California Los Angeles (UCLA) — Los Angeles, California, United States
- Stanford University — Stanford, California, United States
- Sarah Cannon - Denver — Denver, Colorado, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- University of Kansas Cancer Center — Westwood, Kansas, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Memorial Sloan-Kettering — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Cleveland Clinic - Taussig Cancer Institute — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Sarah Cannon Research Center — Nashville, Tennessee, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Baylor Cancer Hospital — Dallas, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Swedish Cancer Institute — Seattle, Washington, United States
- IRCCS Ospedale San Raffaele — Milan, Italy
Full record on ClinicalTrials.gov
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