UPCC 44417 Long-Term Follow-Up Protocol for Subjects Treated with Gene-Modified T Cells

Study on Long-Term Effects of Gene-Modified T Cell Therapy

UPCC 44417 Long-Term Follow-Up Protocol for Subjects Treated with Gene-Modified T Cells
Enrolling By Invitation
All
Phase 2/3
1541 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neoplasms
  • Gender: All

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

This study investigates the long-term safety and efficacy of gene-modified T-cell therapy in both children and adults. The purpose is to observe participants who have previously received this therapy in a Celgene or Celgene alliance partner study.

Participants will be monitored over time to assess the effects of the gene-modified T cells. This involves regular health check-ups and assessments to gather data on the therapy's impact over an extended period.

  • Who can participate: Participants must have received at least one infusion of gene-modified T cells in a previous related trial and completed or discontinued the follow-up period of that study. They must also be able to understand and sign a consent form.
  • Study details: Participants will undergo long-term follow-up assessments to monitor the safety and efficacy of the gene-modified T cells. This includes regular health evaluations as part of the study protocol.
Updated on 28 Jul 2026. Study ID: 17-0359
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