A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SynKIR-110, SynKIR-310.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
Detailed description
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.
Interventions
- Drug SynKIR-110
Autologous T cells Transduced with Mesothelin KIR-CAR - Drug SynKIR-310
Autologous T Cells transduced with CD19 KIR-CAR
Primary outcome measures
- To monitor the long-term safety of participants that have been infused with a 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 [Time frame: Up to 15 years from SynKIR CAR T cell product administration]
Secondary outcome measures (3)
- To assess the long-term clinical efficacy of SynKIR CAR T cell product [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 [Time frame: Up to 15 years from SynKIR CAR T cell product administration]
- To assess the persistence of SynKIR-modified T cells [Time frame: Up to 15 years from SynKIR CAR T cell product administration]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
There are no specific exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute — Denver
- Winship Cancer Institute of Emory University — Atlanta
- University of Kansas Cancer Center — Westwood
- Rutgers Cancer Institute — New Brunswick
- University of Pennsylvania Abramson Cancer Center — Philadelphia
- MD Anderson Cancer Center — Houston
- University of Wisconsin Carbone Cancer Center — Madison
Identifiers
NCT: NCT06701201 · LTFU 101-00