Solid and Hematological Malignancies, Autoimmune Diseases
Conditions
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, 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.
Interventions
BIOLOGICALAxicabtagene Ciloleucel
No investigational product will be administered
BIOLOGICALBrexucabtagene Autoleucel
No investigational product will be administered
BIOLOGICALAnitocabtagene autleucel
No investigational product will be administered
BIOLOGICALKITE-753
No investigational product will be administered
BIOLOGICALKITE-197
No investigational product will be administered
BIOLOGICALKITE-363
No investigational product will be administered
BIOLOGICALINT2104
No investigational product will be administered
BIOLOGICALKITE-512
No investigational product will be administered
BIOLOGICALSPRX001
No investigational product will be administered
BIOLOGICALSPRX002
No investigational product will be administered
BIOLOGICALARC-T Cells
No investigational product will be administered
Sponsors
Kite, A Gilead Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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, and serious infections. |
| 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, and serious infections. |
| Percentage of Participants With New Malignancies | 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. |
| Percentage of Participants Experiencing Related SAEs | Up to 15 years | Adverse events which might be possibly related to the treatment drugs. |
| Height of Pediatric and Adolescent Participants | Up to 15 years | — |
| Weight of Pediatric and Adolescent Participants | Up to 15 years | — |
| Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Subsequent Anticancer Therapies | Up to 15 years | Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs. |
| Survival Status Assessment | 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. |
| Percentage of Participants With Cause of Death | Up to 15 years | — |
| Overall Rate of Replication-competent RCR/RCL | Up to 15 years | — |
| Percentage of Participants With Vector Integration Site(s) for RCR/RCL or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product | Up to 15 years | — |
| Percentage of Participants With Status of Primary Malignant Disease | Up to 15 years | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
STUDY_DIRECTORKite Study Director
Kite, A Gilead Company
Outcome results
None listed