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

Primary Objective

The objectives of this study are as follows: - 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

Study category: Cancer

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Details
Age

Adult

Type of Study

Other

Location

University of Colorado Hospital

Principal Investigator
Manali Kamdar,  MD

Manali Kamdar, MD

Study ID

Protocol Number: 19-0561

More information available at ClinicalTrials.gov: NCT03435796

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