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SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

Primary Purpose

Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease
Adult 18 years of age or older.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
For ovarian cancer and mesothelioma, tumor expression of mesothelin ≥50% of tumor cells with ≥2+ staining intensity (on a scale of 0 to 3). For cholangiocarcinoma ≥10% of cells at any staining intensity (≥1+).
Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma.
Satisfactory Blood coagulation parameters:
Satisfactory organ and bone marrow function

Exclusion Criteria:

Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years.
History of T or B cell malignancies or previous gene-engineered T cell therapies.
Sarcomatoid/biphasic mesothelioma.
Pulmonary exclusions:
Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease
Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening
Active autoimmune disease

Sites / Locations

University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SynKIR-110

Arm Description

Single dose gravity drip IV administration

Outcomes

Primary Outcome Measures

Safety and feasibility of SynKIR-110

• The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, • Incidence of CRS and/or neurologic toxicity

Secondary Outcome Measures

Define the MTD or MFD of SynKIR-110

Full Information

NCT ID

NCT05568680

First Posted

September 28, 2022

Last Updated

September 26, 2023

Sponsor

Verismo Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05568680

Brief Title

SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2023 (Actual)

Primary Completion Date

March 15, 2026 (Anticipated)

Study Completion Date

March 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Verismo Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 initial tumor biomarker screening, followed by an enrollment screening period (which includes pre-leukapheresis safety/eligibility 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 disease progression, 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 assessed 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 enrolled at the MTD/MFD to further assess safety and potential activity of SynKIR-110.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SynKIR-110

Arm Type

Experimental

Arm Description

Single dose gravity drip IV administration

Intervention Type

Biological

Intervention Name(s)

SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR

Intervention Description

Autologous T cells Transduced with Mesothelin KIR-CAR

Primary Outcome Measure Information:

Title

Safety and feasibility of SynKIR-110

Description

• The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, • Incidence of CRS and/or neurologic toxicity

Time Frame

Date of enrollment through date of last patient visit, up to 36 months.

Secondary Outcome Measure Information:

Title

Define the MTD or MFD of SynKIR-110

Description

Define the MTD or MFD of SynKIR-110

Time Frame

Date of enrollment until the MTD is defined, up to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease Adult 18 years of age or older. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. For ovarian cancer and mesothelioma, tumor expression of mesothelin ≥50% of tumor cells with ≥2+ staining intensity (on a scale of 0 to 3). For cholangiocarcinoma ≥10% of cells at any staining intensity (≥1+). Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma. Satisfactory Blood coagulation parameters: Satisfactory organ and bone marrow function Exclusion Criteria: Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years. History of T or B cell malignancies or previous gene-engineered T cell therapies. Sarcomatoid/biphasic mesothelioma. Pulmonary exclusions: Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening Active autoimmune disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Loretta Brozena, BSN, MBA

Phone

267.736.3825

loretta.brozena@verismotherapeutics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Johnson, PhD

Organizational Affiliation

Verismo Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katie Elkins

Phone

215-615-6740

katie.elkins@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

Janos Tanyi, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

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