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

Gilead Sciences

Status and phase

Invitation-only

Phase 2

Conditions

Solid and Hematological Malignancies

Treatments

Biological: KITE-753

Biological: KITE-197

Biological: Axicabtagene Ciloleucel

Biological: Brexucabtagene Autoleucel

Biological: KITE-363

Biological: Anitocabtagene autleucel

Study type

Observational

Funder types

Industry

Identifiers

NCT05041309

2020-005843-21 (EudraCT Number)

KT-US-982-5968

2023-507041-28 (Other Identifier)

MOH_2022-08-21_010606 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
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

Exclusion Criteria: none

Trial design

1,000 participants in 6 patient groups

Axicabtagene Ciloleucel (KTE-C19)

Description:

All participants who previously received axicabtagene ciloleucel (KTE-C19) in the parent study will be enrolled in this cohort for long-term follow-up.

Treatment:

Biological: Axicabtagene Ciloleucel

Brexucabtagene Autoleucel (KTE-X19)

Description:

All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this cohort for long-term follow-up.

Treatment:

Biological: Brexucabtagene Autoleucel

Anitocabtagene autleucel

Description:

All participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up.

Treatment:

Biological: Anitocabtagene autleucel

KITE-753

Description:

All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up.

Treatment:

Biological: KITE-753