Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies

Conditions

• Autoimmune Diseases
• Solid and Hematological Malignancies

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Axicabtagene Ciloleucel — BIOLOGICAL
  No investigational product will be administered
• Brexucabtagene Autoleucel — BIOLOGICAL
  No investigational product will be administered
• Anitocabtagene autleucel — BIOLOGICAL
  No investigational product will be administered
• KITE-753 — BIOLOGICAL
  No investigational product will be administered
• KITE-197 — BIOLOGICAL
  No investigational product will be administered
• KITE-363 — BIOLOGICAL
  No investigational product will be administered
• INT2104 — BIOLOGICAL
  No investigational product will be administered
• KITE-512 — BIOLOGICAL
  No investigational product will be administered
• SPRX001 — BIOLOGICAL
  No investigational product will be administered
• SPRX002 — BIOLOGICAL
  No investigational product will be administered
• ARC-T Cells — BIOLOGICAL
  No investigational product will be administered

Study Details

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.

Key Dates

First listed

Sep 13, 2021

Start date

Dec 15, 2021

Status verified

Sep 2026

Primary completion

Dec 31, 2040

Completion

Dec 31, 2040

Study Design

Enrollment

1,500 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: Anitocabtagene autleucel
  All participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up.
• Arm: KITE-753
  All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up.
• Arm: KITE-197
  All participants who previously received KITE-197 in the parent study will be enrolled in this cohort for long-term follow-up.
• Arm: 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.
• Arm: 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.
• Arm: INT2104
  All participants who previously received INT2104 in the parent study will be enrolled in this cohort for long-term follow-up.
• Arm: KITE-512
  All participants who previously received KITE-512 in the parent study will be enrolled in this cohort for long-term follow-up.
• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) [ Time Frame: Up to 15 years ]

Locations (49)

Find similar trials in Gilbert, AZ

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