Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Mesothelioma

Mesothelioma, Malignant

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Urogenital Neoplasms

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Neoplasms by Histologic Type

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Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Malignant Mesothelioma

Single dose gravity drip IV administration

Autologous T cells Transduced with Mesothelin KIR-CAR

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

Mala K Talekar, MBBS,DABP

Loretta Brozena, BSN, MBA

Katie Elkins

Janos Tanyi, MD, PhD

Rachelle David, BSN,RN

Mehmet Altan, MD

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.

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.

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

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

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

Verismo Therapeutics

Carcinoma, Non-Small-Cell Lung

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Cystic, Mucinous, and Serous

Adenocarcinoma of the Appendix

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Nivolumab

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Ipilimumab

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel

gavo-cel

fludarabine

cyclophosphamide

Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.

This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.

Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer

Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.

To evaluate the efficacy of autologous genetically modified T cells (gavo-cel), with or without immuno-oncology agents, in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate and disease control rate using RECIST v1.1 (or mesothelioma-specific RECIST criteria, if applicable).

Bristol-Myers Squibb

TCR2 Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma	NCT05568680	Ovarian Cancer Cholangiocarcin... Mesothelioma, M...	SynKIR-110, Aut...	18 Years -	Verismo Therapeutics
Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer	NCT03907852	Mesothelioma Mesothelioma, M... Mesothelioma; P... Mesotheliomas P... Mesothelioma Pe... Cholangiocarcin... Cholangiocarcin... Ovarian Cancer Non Small Cell ... Non Small Cell ... High Grade Ovar...	gavo-cel fludarabine cyclophosphamid... Nivolumab Ipilimumab	18 Years -	TCR2 Therapeutics
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma	NCT05568680	Ovarian Cancer Cholangiocarcin... Mesothelioma, M...	SynKIR-110, Aut...	18 Years -	Verismo Therapeutics

Spots Global Cancer Trial Database for cholangiocarcinoma recurrent