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-363, KITE-753, KITE-197, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,000

participants targeted

Target at P75+ for all trials

Timeline

178mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach

13 countries

88 active sites

Status

enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

19 years study duration

Study Progress23%

Dec 2021Dec 2040

First Submitted

Initial submission to the registry

August 27, 2021

Completed

17 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed

19 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2040

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2040

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

19 years

First QC Date

August 27, 2021

Last Update Submit

February 24, 2026

Conditions

Solid and Hematological Malignancies

Outcome Measures

Primary Outcomes (5)

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 new malignancies.
Up to 15 years
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 new malignancies.
Up to 15 years
Height of Pediatric and Adolescent Participants
Up to 15 years
Weight of Pediatric and Adolescent Participants
Up to 15 years
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score
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.
Up to 15 years

Secondary Outcomes (6)

Time to Subsequent Anticancer Therapies
Up to 15 years
Survival Status Assessment
Up to 15 years
Percentage of Participants With Cause of Death
Up to 15 years
Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)
Up to 15 years
Percentage of Participants With 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
Up to 15 years
+1 more secondary outcomes

Study Arms (6)

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.

Biological: Axicabtagene Ciloleucel

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.

Biological: Brexucabtagene Autoleucel

Anitocabtagene autleucel

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

Biological: Anitocabtagene autleucel

KITE-753

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

Biological: KITE-753

KITE-197

All participants who previously received KITE-197 in the parent study will be enrolled in this cohort for long-term follow-up.

Biological: KITE-197

KITE-363

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

Biological: KITE-363