The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
This is a study for the Long Term Follow Up for all participants treated with Verismo Therapeutics' SynKIR CAR T cell products in accordance with regulatory guidance. The primary objective of this study is to monitor the long-term safety of SynKIR CAR T cell products. No investigational product will be administered in this LTFU study. Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product under a Verismo Therapeutics parent protocol. Participants will be invited to enroll into this LTFU study after either early discontinuation from or completion of the parent protocol. In accordance with regulatory guidelines, this study will follow participants for a period of 15 years following infusion of Verismo Therapeutics' SynKIR CAR T cell product, to monitor for delayed adverse events (AEs), detection of replication competent lentivirus (RCL), and to assess long-term efficacy and persistence of gene-modified T cells.
Study Type
OBSERVATIONAL
Enrollment
60
Autologous T cells Transduced with Mesothelin KIR-CAR
Autologous T Cells transduced with CD19 KIR-CAR
Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute
Denver, Colorado, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product
Frequency and severity of delayed AEs considered related to SynKIR CAR T cell product
Time frame: Up to 15 years from SynKIR CAR T cell product administration
To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product
Presence of RCL VSV-G DNA
Time frame: Up to 15 years from SynKIR CAR T cell product administration
To assess the long-term clinical efficacy of SynKIR CAR T cell product
Overall survival
Time frame: Up to 15 years from SynKIR CAR T cell product administration
To assess the long-term clinical efficacy of SynKIR CAR T cell product
Progression-free survival
Time frame: Up to 15 years from SynKIR CAR T cell product administration
To assess the persistence of SynKIR-modified T cells
Presence of a SynKIR CAR DNA sequence
Time frame: Up to 15 years from SynKIR CAR T cell product administration
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University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States