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Long-term follow-up for patients treated with gene-modified T cells

Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

Phase2; Phase3 Interventional Celgene · NCT03435796

This study is checking how well gene-modified T-cell therapy works and what side effects it might have for both kids and adults who have already received this treatment in the past.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment1541 (estimated)
SexAll
SponsorCelgene Industry-sponsored
Locations200 sites (Birmingham, Alabama and 199 other locations)
Trial IDNCT03435796 on ClinicalTrials.gov

What this trial studies

This study focuses on the long-term follow-up of safety and efficacy for individuals who have previously received gene-modified T-cell therapy in earlier trials sponsored by Celgene. Participants, both pediatric and adult, who have completed or discontinued their prior treatment protocols will be invited to enroll in this follow-up study. The aim is to gather comprehensive data on the long-term effects and outcomes of this innovative therapy. The study will monitor participants for any adverse effects and assess the sustained efficacy of the treatment over time.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have previously received at least one infusion of gene-modified T cells in a Celgene-sponsored trial.

Not a fit: Patients who have not received gene-modified T-cell therapy in prior studies will not benefit from this follow-up protocol.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of gene-modified T-cell therapies for cancer treatment.

How similar studies have performed: Other studies involving gene-modified T-cell therapies have shown promising results, indicating that this approach is gaining traction in the field of oncology.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 199 other locations

+150 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NeoplasmsLong-term follow upGene-Modified T CellsCAR T Cell
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.