Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05568680
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2022-09-28
Brief Title:
SynKIR-110 for Mesothelin Expressing Ovarian Cancer Cholangiocarcinoma or Mesothelioma
Sponsor:
Verismo Therapeutics
Organization:
Verismo Therapeutics
Study Overview
Official Title:
A Phase 1 Study of SynKIR-110 Autologous T Cells Transduced With Mesothelin KIR-CAR in Subjects With Mesothelin-Expressing Advanced Ovarian Cancer Cholangiocarcinoma or Mesothelioma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This first-in-human FIH trial is designed to assess the safety feasibility and potential activity of a single intravenous IV dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer mesothelioma and cholangiocarcinoma
Detailed Description:
This is a Phase 1 FIH multicenter open-label dose-escalation pilot study of a single IV gravity drip infusion of SynKIR-110 in subjects with advanced mesothelin-expressing tumors ovarian cancer primary peritoneal cancer fallopian tube cancer cholangiocarcinoma or mesothelioma Up to 42 subjects will be assessed to determine the safety and feasibility of treatment with SynKIR-110 Informed consent will be obtained from subjects prior to participation in this study
The study includes an enrollment screening period which includes pre-leukapheresis safetyeligibility and leukapheresis visits treatment period administration of non-myeloablative lymphodepleting chemotherapy followed by a single infusion of investigational product and a 12-month follow-up period or until disease progression Subjects will be followed for 12 months or until confirmed disease progression whichever occurs first at which point they will be invited to participate in a long-term safety follow-up study
Up to 6 cohorts of 3 to 6 subjects per cohort will be treated to determine the safety and feasibility of treatment with SynKIR-110 Doses will be escalated following a standard 3 3 design until either an MTD or MFD is reached An additional 6 to 9 subjects will be treated at the MTDMFD to further assess safety and potential activity of SynKIR-110
The study includes an enrollment screening period which includes pre-leukapheresis safetyeligibility and leukapheresis visits treatment period administration of non-myeloablative lymphodepleting chemotherapy followed by a single infusion of investigational product and a 12-month follow-up period or until disease progression Subjects will be followed for 12 months or until confirmed disease progression whichever occurs first at which point they will be invited to participate in a long-term safety follow-up study
Up to 6 cohorts of 3 to 6 subjects per cohort will be treated to determine the safety and feasibility of treatment with SynKIR-110 Doses will be escalated following a standard 3 3 design until either an MTD or MFD is reached An additional 6 to 9 subjects will be treated at the MTDMFD to further assess safety and potential activity of SynKIR-110
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None