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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05041309
Recruitment Status : Enrolling by invitation
First Posted : September 13, 2021
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Study Description
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Brief Summary:

The primary objectives of this study are to:

  • Evaluate the incidence and severity of late-onset targeted adverse events (AEs)/serious adverse events (SAEs) suspected to be possibly related to gene-modified cells, including neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies
  • Evaluate mechanism of replication-competent retrovirus/replication-competent lentivirus (RCR/RCL) and/or insertional mutagenesis for confirmed events related to the cell therapy product
  • Evaluate the growth, development, and sexual maturity of pediatric and adolescent subjects treated with gene-modified cells

Condition or disease Intervention/treatment Phase
Solid and Hematological Malignancies Biological: Axicabtagene Ciloleucel Biological: Brexucabtagene Autoleucel Biological: KITE-585 Biological: KITE-718 Biological: KITE-439 Biological: KITE-222 Biological: KITE-363 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Axicabtagene Ciloleucel (KTE-C19 )
All participants who previously received axicabtagene ciloleucel (KTE-C19 ) in the parent study will be enrolled in this arm for long-term follow-up.
 Biological: Axicabtagene Ciloleucel
No investigational product will be administered
Other Name: Yescarta®
Experimental: Brexucabtagene Autoleucel (KTE-X19)
All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this arm for long-term follow-up.
 Biological: Brexucabtagene Autoleucel
No investigational product will be administered
Other Name: Tecartus™
Experimental: KITE-585
All participants who previously received KITE-585 in the parent study will be enrolled in this arm for long-term follow-up.
 Biological: KITE-585
No investigational product will be administered
Experimental: KITE-718
All participants who previously received KITE-718 in the parent study will be enrolled in this arm for long-term follow-up.
 Biological: KITE-718
No investigational product will be administered
Experimental: KITE-439
All participants who previously received KITE-439 in the parent study will be enrolled in this arm for long-term follow-up.
 Biological: KITE-439
No investigational product will be administered
Experimental: KITE-222
All participants who previously received KITE-222 in the parent study will be enrolled in this arm for long-term follow-up.
 Biological: KITE-222
No investigational product will be administered
Experimental: KITE-363
All participants who previously received KITE-363 in the parent study will be enrolled in this arm for long-term follow-up.
 Biological: KITE-363
No investigational product will be administered


Outcome Measures
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Primary Outcome Measures :
  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, serious infections, and secondary malignancies.

  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, serious infections, and secondary malignancies.

  3. Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product [ Time Frame: Up to 15 years ]
  4. Height of Pediatric and Adolescent Participants [ Time Frame: Up to 15 years ]
  5. Weight of Pediatric and Adolescent Participants [ Time Frame: Up to 15 years ]
  6. Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale [ 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 Outcome Measures :
  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. Cause of Death [ Time Frame: Up to 15 years ]
  4. Peripheral B-cell and Lymphocytes Levels for Immune Reconstitution [ Time Frame: Up to 15 years ]
  5. Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) [ Time Frame: Up to 15 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria: none

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041309


Locations
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Sponsors and Collaborators
Kite, A Gilead Company
Investigators
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Study Director: Kite Study Director Kite, A Gilead Company
More Information
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Additional Information:

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Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT05041309    
Other Study ID Numbers: KT-US-982-5968
2020-005843-21 ( EudraCT Number )
MOH_2022-08-21_010606 ( Registry Identifier: Israel Clinical Research Site )
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases