Brief 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, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.
Brief Title
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Solid and Hematological Malignancies
Eligibility 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individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable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
* 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individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable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
Inclusion 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individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT05041309
Org Class
Industry
Org Full Name
Gilead Sciences
Org Study Id
KT-US-982-5968
Overall Status
Enrolling by invitation
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
Outcome Time Frame
Up to 15 years
Outcome Description
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.
Outcome Measure
Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)
Outcome Time Frame
Up to 15 years
Outcome Measure
Height of Pediatric and Adolescent Participants
Outcome Time Frame
Up to 15 years
Outcome Measure
Weight of Pediatric and Adolescent Participants
Outcome Time Frame
Up to 15 years
Outcome Description
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.
Outcome Measure
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score
Outcome Time Frame
Up to 15 years
Secondary Ids
Secondary Id
2020-005843-21
Secondary Id
MOH_2022-08-21_010606
Secondary Id
2023-507041-28
Secondary Id
2023-507041-28
Secondary Outcomes
Outcome Description
Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.
Outcome Time Frame
Up to 15 years
Outcome Measure
Time to Subsequent Anticancer Therapies
Outcome Description
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.
Outcome Time Frame
Up to 15 years
Outcome Measure
Survival Status Assessment
Outcome Time Frame
Up to 15 years
Outcome Measure
Percentage of Participants With Cause of Death
Outcome Time Frame
Up to 15 years
Outcome Measure
Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)
Outcome Time Frame
Up to 15 years
Outcome Measure
Percentage of Participants With 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
Outcome Time Frame
Up to 15 years
Outcome Measure
Percentage of Participants With Status of Primary Malignant Disease
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
The participants who received an infusion of gene-modified cells and have not died, withdrawn consent, been withdrawn by the investigator, or been lost to follow-up at the time of transition from the completed parent study.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mendel Goldfinger
Investigator Email
MGOLDFIN@MONTEFIORE.ORG
Investigator Phone
718-920-4826