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NCT Number: NCT05041309

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.

Enrolling by invitation

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Key information

Conditions

Solid and Hematological Malignancies Autoimmune Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axicabtagene Ciloleucel

Biological

No investigational product will be administered

Other names: Yescarta®

Brexucabtagene autoleucel

Biological

No investigational product will be administered

Other names: Tecartus™

Anitocabtagene autleucel

Biological

No investigational product will be administered

Other names: CART-ddBCMA

KITE-753

Biological

No investigational product will be administered

KITE-197

Biological

No investigational product will be administered

KITE-363

Biological

No investigational product will be administered

INT2104

Biological

No investigational product will be administered

KITE-512

Biological

No investigational product will be administered

SPRX001

Biological

No investigational product will be administered

SPRX002

Biological

No investigational product will be administered

ARC-T Cells

Biological

No investigational product will be administered

Primary outcomes

  1. Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)

    Time frame: 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, and serious infections.

  2. Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)

    Time frame: 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, and serious infections.

  3. Percentage of Participants With New Malignancies

    Time frame: Up to 15 years

    New malignancies regardless of causality includes time to development of the new malignancy, type, location, staging, and molecular mechanism (including testing for presence of the CAR transgene and (replication-competent retrovirus/replication-competent lentivirus (RCR/RCL)). Also to assess the occurrence of all related SAEs that do not fall under the umbrella of targeted events.

  4. Percentage of Participants Experiencing Related SAEs

    Time frame: Up to 15 years

    Adverse events which might be possibly related to the treatment drugs.

  5. Height of Pediatric and Adolescent Participants

    Time frame: Up to 15 years

  6. Weight of Pediatric and Adolescent Participants

    Time frame: Up to 15 years

  7. Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score

    Time frame: Up 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.

Secondary outcomes

  1. Time to Subsequent Anticancer Therapies

    Time frame: Up to 15 years

    Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.

  2. Survival Status Assessment

    Time frame: Up to 15 years

    Survival status will be assessed as the length of time from the participant's first dose date of study drug to death during the study due to any cause or last date of being alive during the study. Survival status will be assessed only per regulatory request or sponsor needs.

  3. Percentage of Participants With Cause of Death

    Time frame: Up to 15 years

  4. Overall Rate of Replication-competent RCR/RCL

    Time frame: Up to 15 years

  5. Percentage of Participants With Vector Integration Site(s) for RCR/RCL or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product

    Time frame: Up to 15 years

  6. Percentage of Participants With Status of Primary Malignant Disease

    Time frame: Up to 15 years

Interested in participating?

Enrolling by invitation

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Kite, A Gilead Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2040
Study completion
2040
First posted
Sep 13, 2021
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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