Cancer
Conditions
Brief summary
The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin.
Detailed description
This study has been designed in adherence with the following Food and Drug Administration (FDA) Guidance documents for Industry: the January 2020 Long-Term Follow-Up After Administration of Human Gene Therapy Products; the January 2020 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; and the March 2022 Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. The study serves to collect data on delayed adverse events for up to fifteen (15) years following a single infusion of SynKIR-110 administered to advance cancer patients with mesothelin expressing tumors. For subjects who have not progressed and have rolled onto this LTFU study at 12 months, data on long-term clinical activity will be collected from the subject's standard of care treatment/medical records. Safety monitoring for delayed adverse events related to SynKIR-110 will include physical examinations, laboratory assessments including complete blood counts, complete metabolic profile, RCL testing and testing for persistence of lentiviral mediated T cells. Testing for persistence of vector sequences by PCR in subjects' blood (and possibly other surrogate tissue) samples will be done at intervals no greater than 6 months for the first five years and then no greater than annually for the next 10 years, or until such time that no vector sequences are detectable in the subjects' sample. Subject samples will be collected for RCL (qPCR for VSV-G) assessment at 3, 6, and 12 months after SynKIR-110 infusion and yearly for up to fifteen (15) years. If all RCL tests within the first year are negative for an individual patient, collection of the yearly follow-up samples may be discontinued for that individual.
Interventions
None listed
Sponsors
Verismo Therapeutics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who have received any amount of SynKIR-110 in a study sponsored by Verismo Therapeutics. 2. Adult 18 years of age or older
Exclusion criteria
1. Unable or unwilling to provide written informed consent 2. Unable or unwilling to comply with the study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with treatment related adverse events as assessed by CTCAE v5.0 | 15 years from date subject received SynKIR-110 | Monitor for signs of SynKIR-110 related delayed adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with persistence of SynKIR-110 modified cells | 15 years from date subject received SynKIR-110 | Monitor qPCR of peripheral blood for persistence of SynKIR-110 modified T cells. |
| Number of subjects with potential/suspected RCL | 15 years from date subject received SynKIR-110 | Monitor qPCR of peripheral blood for VSV-G DNA |
Countries
United States
Outcome results
None listed