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

Primary Purpose

Solid and Hematological Malignancies

Status
Enrolling by invitation
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Axicabtagene Ciloleucel
Brexucabtagene Autoleucel
KITE-585
KITE-718
KITE-439
KITE-222
KITE-363
Sponsored by
Kite, A Gilead Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Solid and Hematological Malignancies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable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

Sites / Locations

  • Banner MD Anderson Cancer Center
  • City of Hope
  • UC San Diego Moores Cancer Center
  • University of California Los Angeles
  • Stanford University
  • University of California Davis Comprehensive Cancer Center
  • Colorado Blood Cancer Institute
  • Sylvester Comprehensive Cancer Centre
  • Moffitt Cancer Center
  • University of Chicago Medical Center Clinical Laboratories
  • Loyola University Medical Center
  • University of Iowa
  • The University of Kansas Cancer Center Westwood
  • University of Maryland Greenebaum Comprehensive Cancer Center
  • Dana-Farber Cancer Institute
  • Karmanos Cancer Center Institute
  • Washington University
  • University of Nebraska
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Montefiore Medical Center
  • Columbia University Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • University of Rochester Medical Center
  • Mayo Clinic
  • DUHS-Duke Blood Cancer Center
  • Cleveland Clinic
  • James Cancer Hospital and Solove Research Institute
  • Tennessee Oncology, PLLC
  • Vanderbilt University
  • The University of Texas MD Anderson Cancer Center
  • Swedish Cancer Institute
  • Fred Hutchinson Cancer Center
  • Peter MacCallum Cancer Centre
  • Princess Margaret Cancer Center - University Health Network
  • Vancouver General Hospital
  • Hopital Saint-Louis
  • CHU Bordeaux, Hopital Haut-Leveque
  • Hôpital Pontchaillou - CHU de Rennes
  • Universitatsklinikum Carl Gustav Carus
  • LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III
  • Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin
  • Tel Aviv Souraski Medical Center
  • Amsterdam Universitair Medische Centra (UMC)
  • University Medical Centre Groningen
  • Erasmus University Medical Centre (MC)
  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Axicabtagene Ciloleucel (KTE-C19 )

Brexucabtagene Autoleucel (KTE-X19)

KITE-585

KITE-718

KITE-439

KITE-222

KITE-363

Arm Description

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

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

All participants who previously received KITE-585 in the parent study will be enrolled in this arm for long-term follow-up.

All participants who previously received KITE-718 in the parent study will be enrolled in this arm for long-term follow-up.

All participants who previously received KITE-439 in the parent study will be enrolled in this arm for long-term follow-up.

All participants who previously received KITE-222 in the parent study will be enrolled in this arm for long-term follow-up.

All participants who previously received KITE-363 in the parent study will be enrolled in this arm for long-term follow-up.

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies.
Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)
Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies.
Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product
Height of Pediatric and Adolescent Participants
Weight of Pediatric and Adolescent Participants
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale
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.

Secondary Outcome Measures

Time to Subsequent Anticancer Therapies
Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.
Survival Status Assessment
Survival status will be assessed as the length of time from the participant's first dose date of study drug to death during the study due to any cause or last date of being alive during the study. Survival status will be assessed only per regulatory request or sponsor needs.
Cause of Death
Peripheral B-cell and Lymphocytes Levels for Immune Reconstitution
Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)

Full Information

First Posted
August 27, 2021
Last Updated
October 6, 2023
Sponsor
Kite, A Gilead Company
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1. Study Identification

Unique Protocol Identification Number
NCT05041309
Brief Title
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Official Title
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
March 2041 (Anticipated)
Study Completion Date
March 2041 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kite, A Gilead Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid and Hematological Malignancies

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Axicabtagene Ciloleucel (KTE-C19 )
Arm Type
Experimental
Arm Description
All participants who previously received axicabtagene ciloleucel (KTE-C19 ) in the parent study will be enrolled in this arm for long-term follow-up.
Arm Title
Brexucabtagene Autoleucel (KTE-X19)
Arm Type
Experimental
Arm Description
All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this arm for long-term follow-up.
Arm Title
KITE-585
Arm Type
Experimental
Arm Description
All participants who previously received KITE-585 in the parent study will be enrolled in this arm for long-term follow-up.
Arm Title
KITE-718
Arm Type
Experimental
Arm Description
All participants who previously received KITE-718 in the parent study will be enrolled in this arm for long-term follow-up.
Arm Title
KITE-439
Arm Type
Experimental
Arm Description
All participants who previously received KITE-439 in the parent study will be enrolled in this arm for long-term follow-up.
Arm Title
KITE-222
Arm Type
Experimental
Arm Description
All participants who previously received KITE-222 in the parent study will be enrolled in this arm for long-term follow-up.
Arm Title
KITE-363
Arm Type
Experimental
Arm Description
All participants who previously received KITE-363 in the parent study will be enrolled in this arm for long-term follow-up.
Intervention Type
Biological
Intervention Name(s)
Axicabtagene Ciloleucel
Other Intervention Name(s)
Yescarta®
Intervention Description
No investigational product will be administered
Intervention Type
Biological
Intervention Name(s)
Brexucabtagene Autoleucel
Other Intervention Name(s)
Tecartus™
Intervention Description
No investigational product will be administered
Intervention Type
Biological
Intervention Name(s)
KITE-585
Intervention Description
No investigational product will be administered
Intervention Type
Biological
Intervention Name(s)
KITE-718
Intervention Description
No investigational product will be administered
Intervention Type
Biological
Intervention Name(s)
KITE-439
Intervention Description
No investigational product will be administered
Intervention Type
Biological
Intervention Name(s)
KITE-222
Intervention Description
No investigational product will be administered
Intervention Type
Biological
Intervention Name(s)
KITE-363
Intervention Description
No investigational product will be administered
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
Description
Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies.
Time Frame
Up to 15 years
Title
Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)
Description
Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies.
Time Frame
Up to 15 years
Title
Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product
Time Frame
Up to 15 years
Title
Height of Pediatric and Adolescent Participants
Time Frame
Up to 15 years
Title
Weight of Pediatric and Adolescent Participants
Time Frame
Up to 15 years
Title
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale
Description
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.
Time Frame
Up to 15 years
Secondary Outcome Measure Information:
Title
Time to Subsequent Anticancer Therapies
Description
Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.
Time Frame
Up to 15 years
Title
Survival Status Assessment
Description
Survival status will be assessed as the length of time from the participant's first dose date of study drug to death during the study due to any cause or last date of being alive during the study. Survival status will be assessed only per regulatory request or sponsor needs.
Time Frame
Up to 15 years
Title
Cause of Death
Time Frame
Up to 15 years
Title
Peripheral B-cell and Lymphocytes Levels for Immune Reconstitution
Time Frame
Up to 15 years
Title
Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)
Time Frame
Up to 15 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kite Study Director
Organizational Affiliation
Kite, A Gilead Company
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Sylvester Comprehensive Cancer Centre
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago Medical Center Clinical Laboratories
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The University of Kansas Cancer Center Westwood
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Maryland Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Center Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
New York
ZIP/Postal Code
55905
Country
United States
Facility Name
DUHS-Duke Blood Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
James Cancer Hospital and Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43220
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Princess Margaret Cancer Center - University Health Network
City
Toronto
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Bordeaux, Hopital Haut-Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Pontchaillou - CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Universitatsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Tel Aviv Souraski Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Amsterdam Universitair Medische Centra (UMC)
City
Amsterdam
ZIP/Postal Code
1100
Country
Netherlands
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Erasmus University Medical Centre (MC)
City
Rotterdam
ZIP/Postal Code
3011PL
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=KT-US-982-5968
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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