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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
Details
Age
Adult
Phase
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
Type of Study
Other
Location
University of Colorado Hospital
Principal Investigator
Manali Kamdar, MD, PhD
Study ID
Protocol Number: 19-0561
More information available at ClinicalTrials.gov: NCT03435796
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