Clinical trial NCT06377202: Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110 in Cancer Studies
Official title: Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110, Autologous T Cells Transduced with Mesothelin KIR-CAR, in Cancer Studies
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Lead sponsor: Verismo Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who recieved SynKIR-110

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with treatment related adverse events as assessed by CTCAE v5.0
timeFrame: 15 years from date subject received SynKIR-110
Secondary outcomes:
measure: Number of subjects with persistence of SynKIR-110 modified cells
timeFrame: 15 years from date subject received SynKIR-110
measure: Number of subjects with potential/suspected RCL
timeFrame: 15 years from date subject received SynKIR-110
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Verismo Therapeutics
name: Laura Johnson, PhD
role: STUDY_DIRECTOR
References: