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

Conditions

• 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

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, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.

Key Dates

Start date

Dec 15, 2021

Status verified

May 2026

Primary completion

Dec 31, 2040

Completion

Dec 31, 2040

Study Design

Enrollment

1,000 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
  All participants who previously received KITE-363 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)

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