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Enrolling By Invitation NCT05041309

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

Conditions: Solid and Hematological Malignancies, Autoimmune Diseases

Sex: All
Healthy volunteers: No
Enrollment: 1500
Sponsor: Kite, A Gilead Company

Location: Banner MD Anderson Cancer Center Gilbert Arizona

Summary

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.

Eligibility Criteria

Inclusion Criteria: * The individual must have been administered gene-modified cell therapy or completed the post-treatment follow-up period in the parent study, as applicable * The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted * In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation Exclusion Criteria: none

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05041309). StuddyBuddy aggregates publicly available trial information.