Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Study Details
Study Description
Brief Summary
The primary objectives of this study are to:
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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
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Evaluate mechanism of replication-competent retrovirus/replication-competent lentivirus (RCR/RCL) and/or insertional mutagenesis for confirmed events related to the cell therapy product
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Evaluate the growth, development, and sexual maturity of pediatric and adolescent subjects treated with gene-modified cells
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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 Names:
|
| 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 Names:
|
| 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
Primary Outcome Measures
- 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, serious infections, and secondary malignancies.
- 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, serious infections, and secondary malignancies.
- 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 [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
- 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.
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope | Duarte | California | United States | 91010 |
| 2 | Stanford University | Palo Alto | California | United States | 94305 |
| 3 | Colorado Blood Cancer Institute | Denver | Colorado | United States | 80218 |
| 4 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 5 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 6 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 7 | Tennessee Oncology, PLLC | Nashville | Tennessee | United States | 37203 |
| 8 | Vanderbilt University | Nashville | Tennessee | United States | 37232 |
| 9 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Kite, A Gilead Company
Investigators
- Study Director: Kite Study Director, Kite, A Gilead Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- KT-US-982-5968
- 2020-005843-21