Clinical trial · Interventional
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gene-modified (GM) T cell therapy | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Participants exposed to Gene-modified (GM) T cell therapy
- interventionNames
- Genetic: Gene-modified (GM) T cell therapy
Primary outcomes (8)
- measure
- Incidence of delayed Adverse Events (AEs)
- timeFrame
- Up to 15 years from last gene-modified (GM) T cell infusion
- measure
- Persistence of GM T cell drug products
- timeFrame
- Up to 15 years from last GM T cell infusion
- measure
- Analysis of vector integration sites
- timeFrame
- Up to 15 years from last GM T cell infusion
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable. * Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted. Exclusion Criteria: Not Applicable Other protocol-defined inclusion/exclusion criteria apply
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Jeremy S Abramson, Tanya Siddiqi, Leo I Gordon et al. · Blood · Sep 10, 2026 · PMID 42237652 pubmed
- DERIVEDWierda WG, Dorritie KA, Gauthier J, Nath R, Kipps TJ, Riedell PA, Eradat HA, Kenderian SS, Kharfan-Dabaja MA, Shah NN, Solomon SR, Stephens DM, Ermann DA, Arnason JE, Deol A, Feldman TA, Andreadis CB, Ghosh M, Ma S, Schuster SJ, Gergis U, Vose JM, Soumerai JD, van Besien K, Tuazon SA, Perna SK, Ou SS, Ananthakrishnan R, Rane N, Papp E, Ansari S, Thompson EG, Okal A, Peiser L, Chen Y, Sengupta S, Ray PR, Wang J, Siddiqi T. Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004. Blood. 2026 Jul 28:blood.2026033565. doi: 10.1182/blood.2026033565. Online ahead of print. PMID 42520199
- DERIVEDAbramson JS, Siddiqi T, Gordon LI, Lunning MA, Wang M, Arnason JE, Kamdar M, Maloney DG, Shadman M, Andreadis CB, Sehgal A, Solomon SR, Ghosh N, Hidalgo-Lopez JE, Wang J, Ding X, Ogasawara K, Singh A, Palomba ML. Five-year survival outcomes from TRANSCEND NHL 001 of lisocabtagene maraleucel in R/R LBCL. Blood. 2026 Jun 3:blood.2025032270. doi: 10.1182/blood.2025032270. Online ahead of print.