Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, anitocabtagene autoleucel, INT2104, KITE-512, ACLX-001, and ACLX002 in participants of Kite-sponsored interventional studies. The primary objectives of this study are to: - Evaluate the incidence and severity of related SAEs, late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cell therapy, including neurologic disorders, new autoimmune disorders (which are distinct from the study-treated disease), hematologic disorders, serious infections, as well as any new malignancies (regardless of causality) - Evaluate the growth, development, and sexual maturity of pediatric and adolescent participants treated with gene-modified cell therapy.

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05041309.

Trial PhaseNo phase specified

Trial TypeNot provided by clinicaltrials.gov

Lead OrganizationKite, A Gilead Company

• Primary IDKT-US-982-5968
• Secondary IDsNCI-2022-00867, 2020-005843-21, 2023, 2023-507041-28, MOH_2022-08-21_010606
• ClinicalTrials.gov IDNCT05041309