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Trial record 2 of 2 for:    synkir
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Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies

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ClinicalTrials.gov Identifier: NCT06377202
Recruitment Status : Recruiting
First Posted : April 22, 2024
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Verismo Therapeutics

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 15, 2023
Estimated Primary Completion Date : December 15, 2038
Estimated Study Completion Date : December 15, 2038
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with treatment related adverse events as assessed by CTCAE v5.0 [ Time Frame: 15 years from date subject received SynKIR-110 ]
    Monitor for signs of SynKIR-110 related delayed adverse events


Secondary Outcome Measures :
  1. Number of subjects with persistence of SynKIR-110 modified cells [ Time Frame: 15 years from date subject received SynKIR-110 ]
    Monitor qPCR of peripheral blood for persistence of SynKIR-110 modified T cells.

  2. Number of subjects with potential/suspected RCL [ Time Frame: 15 years from date subject received SynKIR-110 ]
    Monitor qPCR of peripheral blood for VSV-G DNA


Biospecimen Retention:   Samples With DNA
PBMC (RCL-VSV-G) Whole Blood (qPCR persistence)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects who recieved SynKIR-110
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06377202


Contacts
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Contact: Mala K Talekar, MBBS, DAPB 267.331.3800 mala.talekar@verismotherapeutics.com
Contact: Andrea Campanile, MS andrea.campanile@verismotherapeutics.com

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katie Elkins    215-615-6740    katie.elkins@pennmedicine.upenn.edu   
Principal Investigator: Janos Tanyi, MD, PhD         
Sponsors and Collaborators
Verismo Therapeutics
Investigators
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Study Director: Mala K Talekar, BBS, DABP Verismo Therapeutics
More Information
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Responsible Party: Verismo Therapeutics
ClinicalTrials.gov Identifier: NCT06377202    
Other Study ID Numbers: SynKIR-110 LTFU
First Posted: April 22, 2024    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No