Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT06377202
Status:
WITHDRAWN
Last Update Posted:
2024-11-07
First Post:
2024-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110 in Cancer Studies
Sponsor:
Verismo Therapeutics
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study is being withdrawn and replaced by a new multicenter LTFU Basket Study, designed to monitor the long-term safety of all SynKIR CAR T cell products. This updated study will include all participants who have been treated with Verismo Therapeu
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: