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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
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
Start Date
January 27, 2025
Primary Completion Date
February 1, 2042
Completion Date
February 1, 2042
Last Updated
February 10, 2026
60
ESTIMATED participants
SynKIR-110
DRUG
SynKIR-310
DRUG
Lead Sponsor
Verismo Therapeutics
NCT05691465
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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