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MT2019-07: LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

Recruiting

This study is designed for the following purpose: - To assess the risk of delayed adverse events (AEs) following exposure to genemodified(GM) T cells - To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate. - To monitor for generation of replication competent retroviruses (RCR) - To assess long-term efficacy following treatment with GM T cells - Describe growth, developmental outcome, and sexual maturity status for subjects who were aged < 18 years at time of GM T cell treatment - To assess long term health-related quality of life following treatment with GM T cells

I'm interested

All
Not specified
This study is NOT accepting healthy volunteers
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

Genetic: Gene-modified (GM) T cell therapy

Neoplasms

Long-term follow up, Gene-Modified T Cells, CAR T Cell, Clinics and Surgery Center (CSC)

Veronika Bachanova - bach0173@umn.edu
Veronika Bachanova, MD
Phase 2/Phase 3
STUDY00006610
NCT03435796
See this study on ClinicalTrials.gov

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