NCT06377202

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
154mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Nov 2023Dec 2038

Study Start

First participant enrolled

November 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
14.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2038

Last Updated

November 7, 2024

Status Verified

April 1, 2024

Enrollment Period

15.1 years

First QC Date

April 10, 2024

Last Update Submit

November 5, 2024

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of subjects with persistence of SynKIR-110 modified cells

    15 years from date subject received SynKIR-110

  • Number of subjects with potential/suspected RCL

    15 years from date subject received SynKIR-110

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who recieved SynKIR-110

You may qualify if:

  • Subjects who have received any amount of SynKIR-110 in a study sponsored by Verismo Therapeutics.
  • Adult 18 years of age or older

You may not qualify if:

  • Unable or unwilling to provide written informed consent
  • Unable or unwilling to comply with the study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

PBMC (RCL-VSV-G) Whole Blood (qPCR persistence)

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Laura Johnson, PhD

    Verismo Therapeutics

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 22, 2024

Study Start

November 15, 2023

Primary Completion (Estimated)

December 15, 2038

Study Completion (Estimated)

December 15, 2038

Last Updated

November 7, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)