Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT05568680

Reclutamento in corso

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

Interventistico

Fase 1

University of Pennsylvania

Sponsor: Verismo Therapeutics

Ultimo Aggiornamento: 10 febbraio 2026
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Terapia Cellulare

Mutazioni richieste

Mesothelin

Studio Iniziato

30 marzo 2023

Ultimo Aggiornamento dello Sponsor

10 febbraio 2026

Completamento Stimato

1 dicembre 2027

Contatto dello studio

Nome:Physician Connect

Email:physician.connect@verismotherapeutics.com

Telefono:267-392-6847

Idoneità

Criteri di Inclusione

* 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.

* 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

Criteri di Esclusione

* 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.

* 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

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Dettagli del Disegno

AllocazioneN/A

Modello di InterventoSingle Group Assignment

MascheramentoNone (Open Label)

Numero da Arruolare42

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Single dose gravity drip IV administration

Interventi:

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

Misure di Esito

Misure di Esito Primarie

Safety and Feasibility of SynKIR-110Up to 12 months

* The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, Incidence of CRS and/or neurologic toxicity * Frequency of subjects who pass screening to enrollment but do not receive SynKIR-110

Misure di Esito Secondarie

Define the maximum tolerated dose (MTD)/maximum feasible dose (MFD) of SynKIR-110 and to identify a recommended Phase 2 doseUp to 12 months

Define the MTD or MFD of SynKIR-110

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Siti dello Studio

Questo studio ha 4 siti

University of Pennsylvania

Philadelphia, Pennsylvania, US

Nome:Andrea Standish

Email:andrea.standish@pennmedicine.upenn.edu

Telefono:215-662-2419

In fase di reclutamento

Philadelphia, Pennsylvania, 19104 US

University of Pennsylvania

In fase di reclutamento

Houston, Texas, 77030 US

MD Anderson Cancer Center

In fase di reclutamento

Westwood, Kansas, 66205 US

University of Kansas Cancer Center

In fase di reclutamento

Madison, Wisconsin, 53792 US

University of Wisconsin Carbone Cancer Center

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