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

Study Overview
=================
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-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

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

Conditions
-----------------
Solid and Hematological Malignancies

Intervention / Treatment
-----------------
* Biological: Axicabtagene Ciloleucel
* Biological: Brexucabtagene Autoleucel
* Biological: KITE-585
* Biological: KITE-718
* Biological: KITE-439
* Biological: KITE-222
* Biological: KITE-363


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individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable The individual must understand and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

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axicabtagene Ciloleucel (KTE-C19 )<br>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<br>* No investigational product will be administered<br>* Other names: Yescarta®;|
| Experimental: Brexucabtagene Autoleucel (KTE-X19)<br>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<br>* No investigational product will be administered<br>* Other names: Tecartus™;|
| Experimental: KITE-585<br>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<br>* No investigational product will be administered<br>|
| Experimental: KITE-718<br>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<br>* No investigational product will be administered<br>|
| Experimental: KITE-439<br>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<br>* No investigational product will be administered<br>|
| Experimental: KITE-222<br>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<br>* No investigational product will be administered<br>|
| Experimental: KITE-363<br>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<br>* No investigational product will be administered<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) | 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. | Up to 15 years | 
| Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs) | 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. | Up to 15 years | 
| 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 |  | Up to 15 years | 
| 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 | 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. | Up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Subsequent Anticancer Therapies | Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs. | Up to 15 years | 
| Survival Status Assessment | 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. | Up to 15 years | 
| Cause of Death |  | Up to 15 years | 
| Peripheral B-cell and Lymphocytes Levels for Immune Reconstitution |  | Up to 15 years | 
| Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) |  | Up to 15 years |