Clinical trial · Observational
Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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. 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Diseases | — | UNRESOLVED | — |
| Solid and Hematological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anitocabtagene autleucel | Biological | — | UNRESOLVED |
| ARC-T Cells | Biological | — | UNRESOLVED |
| Axicabtagene Ciloleucel | Biological | Axicabtagene Ciloleucel | ALIAS |
| Brexucabtagene Autoleucel | Biological | Brexucabtagene Autoleucel | ALIAS |
| INT2104 | Biological | — | UNRESOLVED |
| KITE-197 | Biological | — | UNRESOLVED |
| KITE-363 | Biological | — | UNRESOLVED |
| KITE-512 | Biological | — | UNRESOLVED |
| KITE-753 |
Design
Arms and outcomes
Arms (11)
- label
- 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.
- interventionNames
- Biological: Axicabtagene Ciloleucel
- label
- 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.
- interventionNames
- Biological: Brexucabtagene Autoleucel
- label
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: none
References
Publications (1)
- DERIVEDMunoz J, Locke FL, Reagan PM, Goy A, Jacobson CA, Hill BT, Timmerman JM, Flinn IW, Miklos DB, Pagel JM, Kersten MJ, Forcade E, Topp MS, Houot R, Beitinjaneh A, Zheng D, Chang M, Zhang W, Shen RR, Khalid RD, Kloos I, Wang ML. Five-year follow-up of patients with relapsed/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2. J Hematol Oncol. 2026 Apr 27;19(1):39. doi: 10.1186/s13045-026-01797-4. PMID 42036693