Clinical Trial
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Investigator
Complete title:
Long-term Follow-Up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Trial phase:
Phase
II
Study ID:
NCT05041309
Local study ID:
RG1122504
Summary:
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
Trial keywords:
Solid Tumors
Enrollment status:
Recruiting
Trial eligibility
** For Eligibility information, please click on the "Look up trial at NIH" link above **
Other eligibility criteria may apply.
Other eligibility criteria may apply.
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