Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Sponsor: Celgene
ClinicalTrials ID:NCT03435796
This study monitors long-term safety and efficacy in participants who received GM T cell therapy in prior Celgene studies. Eligible individuals must have completed or discontinued the parent protocol and consent to participate. No new investigational product is administered, focusing solely on follow-up assessments. Additional protocol-specific criteria may apply.
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Program Overview
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 GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Eligibility Criteria
Inclusion Criteria
- Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, 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
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