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NCT05041309

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Enrolling by Invitation
Not specifiedAll AgesObservational
Kite, A Gilead Company
~1,000 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Axicabtagene CiloleucelBrexucabtagene AutoleucelAnitocabtagene autleucelKITE-753KITE-197KITE-363

At a glance

Recruiting sites
0 of 90 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
Measured over Up to 15 years
+4 more outcomes measured

Conditions

Solid and Hematological Malignancies

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Hematologic NeoplasmSolid Neoplasm

Where it's being run

90 sites across 37 states
California8
New York7
Canada6
France6
Germany6
Japan5
Netherlands5
Texas4

Study leadership

  • Kite Study Director · STUDY_DIRECTOR · Kite, A Gilead Company

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable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

What this trial measures

  • Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)Up to 15 years

    Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies.

  • Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)Up to 15 years

    Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies.

  • Height of Pediatric and Adolescent ParticipantsUp to 15 years
  • Weight of Pediatric and Adolescent ParticipantsUp to 15 years
  • Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale ScoreUp to 15 years

    The Tanner Pubertal Stage Scale is a measure of pubertal development (sexual maturation) in children and adolescents with components described for each sex, rated separately on a scale of stage one to stage five, with 1 for preadolescent and 5 for mature/adult.