SynKIR-110
DrugAutologous T cells Transduced with Mesothelin KIR-CAR
NCT Number: NCT06701201
The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
Interested in participating?
Request InfoThis 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion criteria
There are no specific exclusion criteria.
Autologous T cells Transduced with Mesothelin KIR-CAR
Autologous T Cells transduced with CD19 KIR-CAR
Time frame: Up to 15 years from SynKIR CAR T cell product administration
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
Presence of RCL VSV-G DNA
Time frame: Up to 15 years from SynKIR CAR T cell product administration
Overall survival
Time frame: Up to 15 years from SynKIR CAR T cell product administration
Progression-free survival
Time frame: Up to 15 years from SynKIR CAR T cell product administration
Presence of a SynKIR CAR DNA sequence
Verismo Therapeutics
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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