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Enrolling by invitationPhase 2

Long-term follow-up of people treated with gene-modified cell therapies

Tracks long-term safety of gene-modified cell treatments in people from Kite studies.

Key facts

Who runs it
Kite, A Gilead Company
Where
London, United KingdomSee the 2 sitesAlso in 13 other countries, 90 sites
Registry title
Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies
Status
Enrolling by invitation
Phase
Phase 2
People taking part
1,500 people, planned
Started
15 Dec 2021
Expected to end
Dec 2040
Type of study
Observational, 11 groups
Treatments tested
  • Axicabtagene Ciloleucel
  • Brexucabtagene Autoleucel
  • Anitocabtagene autleucel
  • KITE-753
  • KITE-197
  • KITE-363
  • INT2104
  • KITE-512
  • SPRX001
  • SPRX002
  • ARC-T Cells
Record updated
21 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who received gene-modified cell therapy in a Kite-sponsored study, or finished the follow-up period of that study. It checks long-term safety and effect.

Sex
All sexes can join.
Earlier treatment
People must have received gene-modified cell therapy, or finished the post-treatment follow-up in the earlier Kite study.

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • The individual must have been administered gene-modified cell therapy 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

Where in United Kingdom

Also in 13 other countries, 90 sites

  • King's College HospitalLondon, United KingdomNo longer taking part
  • The Royal Marsden NHS Foundation HospitalLondon, United KingdomNo longer taking part

About the trial

What the trial wants to find out

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, anitocabtagene autoleucel, INT2104, KITE-512, ACLX-001, and ACLX002 in participants of Kite-sponsored interventional studies.

Read full original descriptionShow less

The primary objectives of this study are to:

* Evaluate the incidence and severity of related SAEs, late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cell therapy, including neurologic disorders, new autoimmune disorders (which are distinct from the study-treated disease), hematologic disorders, serious infections, as well as any new malignancies (regardless of causality) * Evaluate the growth, development, and sexual maturity of pediatric and adolescent participants treated with gene-modified cell therapy.

The 11 groups in the trial

  • 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.

    Treatment: 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.

    Treatment: 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.

  • KITE-753

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

  • KITE-197

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

  • KITE-363: Oncology Indication

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

    Treatment: KITE-363

  • KITE-363: Autoimmune Indication

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

    Treatment: KITE-363

  • INT2104

    All participants who previously received INT2104 in the parent study will be enrolled in this cohort for long-term follow-up.

  • KITE-512

    All participants who previously received KITE-512 in the parent study will be enrolled in this cohort for long-term follow-up.

  • ACLX-001 (SPRX001 + ARC-T cells)

    All participants who previously received ACLX-001 in the parent study will be enrolled in this cohort for long-term follow-up.

    Treatment: SPRX001 and ARC-T Cells

  • ACLX002 (SPRX002 + ARC-T cells)

    All participants who previously received ACLX-002 in the parent study will be enrolled in this cohort for long-term follow-up.

    Treatment: SPRX002 and ARC-T Cells

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Plain-language title
Long-term follow-up of people treated with gene-modified cell therapiesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
21 September 2026