A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
1 other identifier
observational
60
1 country
6
Brief Summary
The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2025
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedStudy Start
First participant enrolled
January 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2042
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2042
February 10, 2026
January 1, 2026
17 years
November 18, 2024
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Up to 15 years from SynKIR CAR T cell product administration
Secondary Outcomes (3)
To assess the long-term clinical efficacy of SynKIR CAR T cell product
Up to 15 years from SynKIR CAR T cell product administration
To assess the long-term clinical efficacy of SynKIR CAR T cell product
Up to 15 years from SynKIR CAR T cell product administration
To assess the persistence of SynKIR-modified T cells
Up to 15 years from SynKIR CAR T cell product administration
Study Arms (2)
SynKIR-110
Participants who previously received SynKIR-110 in an interventional trial
SynKIR-310
Participants who previously received SynKIR-310 in an interventional trial
Interventions
Eligibility Criteria
Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product in a Verismo Therapeutics parent protocol.
You may qualify if:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics.
- Participant is willing and able to comply with the study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute
Denver, Colorado, 80218, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2024
First Posted
November 22, 2024
Study Start
January 27, 2025
Primary Completion (Estimated)
February 1, 2042
Study Completion (Estimated)
February 1, 2042
Last Updated
February 10, 2026
Record last verified: 2026-01