Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies

Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110, Autologous T Cells Transduced With Mesothelin KIR-CAR, in Cancer Studies

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mala K Talekar, MBBS, DAPB; Phone Number: 267.331.3800; Email: mala.talekar@verismotherapeutics.com
• Study Contact Backup: Name: Andrea Campanile, MS; Email: andrea.campanile@verismotherapeutics.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Katie Elkins; Phone Number: 215-615-6740; Email: katie.elkins@pennmedicine.upenn.edu
      • Principal Investigator: Janos Tanyi, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects who recieved SynKIR-110

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with treatment related adverse events as assessed by CTCAE v5.0	Monitor for signs of SynKIR-110 related delayed adverse events	15 years from date subject received SynKIR-110

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with persistence of SynKIR-110 modified cells	Monitor qPCR of peripheral blood for persistence of SynKIR-110 modified T cells.	15 years from date subject received SynKIR-110
Number of subjects with potential/suspected RCL	Monitor qPCR of peripheral blood for VSV-G DNA	15 years from date subject received SynKIR-110

Collaborators and Investigators

• Sponsor: Verismo Therapeutics
• Investigators: Study Director: Mala K Talekar, BBS, DABP, Verismo Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 15, 2038
• Study Completion (Estimated): December 15, 2038

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SynKIR-110 LTFU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No