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

First listed

Sep 13, 2021

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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