Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 1,500
- 试验地点
- 91
- 主要终点
- Height of Pediatric and Adolescent Participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
KITE-197
All participants who previously received KITE-197 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: KITE-197 (Biological)
ACLX002 (SPRX002 + ARC-T cells)
All participants who previously received ACLX-002 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: SPRX002 (Biological)
KITE-363: Oncology Indication
All participants who previously received KITE-363 for oncology indication in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: KITE-363 (Biological)
INT2104
All participants who previously received INT2104 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: INT2104 (Biological)
KITE-512
All participants who previously received KITE-512 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: KITE-512 (Biological)
ACLX-001 (SPRX001 + ARC-T cells)
All participants who previously received ACLX-001 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: SPRX001 (Biological)
ACLX-001 (SPRX001 + ARC-T cells)
All participants who previously received ACLX-001 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: ARC-T Cells (Biological)
ACLX002 (SPRX002 + ARC-T cells)
All participants who previously received ACLX-002 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: ARC-T Cells (Biological)
KITE-363: Autoimmune Indication
All participants who previously received KITE-363 for autoimmune indication in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: KITE-363 (Biological)
Axicabtagene Ciloleucel (KTE-C19)
All participants who previously received axicabtagene ciloleucel (KTE-C19) in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: Axicabtagene Ciloleucel (Biological)
Brexucabtagene Autoleucel (KTE-X19)
All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: Brexucabtagene Autoleucel (Biological)
KITE-753
All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: KITE-753 (Biological)
Anitocabtagene autleucel
All participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: Anitocabtagene autleucel (Biological)
结局指标
主要结局
Height of Pediatric and Adolescent Participants
时间窗: Up to 15 years
Weight of Pediatric and Adolescent Participants
时间窗: Up to 15 years
Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: Up to 15 years
Adverse events which might be possibly related to the treatment drugs.
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score
时间窗: 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.
次要结局
- 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)
- Time to Subsequent Anticancer Therapies(Up to 15 years)
- Survival Status Assessment(Up to 15 years)
- Percentage of Participants With Cause of Death(Up to 15 years)
- Percentage of Participants With Status of Primary Malignant Disease(Up to 15 years)