Calendario›TCRT›HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors

HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors

Ensayo de Alaunos Therapeutics, Inc. en Ovarian Cancer · Endometrial Cancer · Colo-rectal Cancer · Cholangiocarcinoma · Non-small Cell Lung Cancer · Pancreas Cancer (del registro, en inglés).

Más ensayos de: Cáncer de ovario · Cáncer de endometrio · Colangiocarcinoma · Cáncer de pulmón no microcítico · Cáncer de páncreas.

Fase

no aplica

Estado

Interrumpido

Participantes

19

previstos

Centros

1

Fin del objetivo primario

ago 2023

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en sep 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «TCR001-002 protocol was combined with TCR001-201 protocol, which was terminated due to business decisions.».

Qué mide

Number of Participants Positive for Human Leukocyte Antigen (HLA)-A*02 (Screening Visit) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a data collection study, also referred to as a "screening" study; no investigational or standard therapy will be administered as part of this study. In order to identify subjects for the Phase I/II study, TCR001-201, patients with following histologically confirmed tumor types will be initially screened in this protocol for their somatic mutation and HLA type: * Gynecologic cancer (ovarian or endometrial) * Colorectal cancer * Pancreatic cancer * Non-small cell lung cancer (NSCLC). NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas * Cholangiocarcinoma Subjects' somatic mutation(s) and HLA type restriction combination will be examined against Alaunos Therapeutics Inc.'s (Alaunos) TCR library to determine if a TCR match is available for that subject. Subjects without a match will be discontinued from this protocol. Subjects with a TCR match in the Alaunos TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, i.e., for progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Subjects will complete participation on this protocol when the subject enrolls on the Phase I/II study or if the subject dies.

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Ficha completa en ClinicalTrials.gov (NCT05124743), actualizada en jul 2025.