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Clinical Trial Details
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Complete Title: Long-term Follow-Up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Trial Phase: II
Investigator: Jordan Gauthier
The primary objectives of this study are to: Evaluate the incidence and severity of late-onset targeted adverse events (AEs)/serious adverse events (SAEs) suspected to be possibly related to gene-modified cells, including neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies Evaluate mechanism of replication-competent retrovirus/replication-competent lentivirus (RCR/RCL) and/or insertional mutagenesis for confirmed events related to the cell therapy product Evaluate the growth, development, and sexual maturity of pediatric and adolescent subjects treated with gene-modified cells
Keywords:
- Solid Tumors
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Adult
Pediatric
II
Jordan Gauthier
RG1122504
NCT05041309
Long-term Follow-Up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Solid Tumors