Clinical Trial

Disease: Metastatic epithelial-derived solid tumors (NCT05239143)

Disease info:

Metastatic epithelial-derived solid tumours is an umbrella term that that includes tumour types such as gastric cancer, pancreatic cancer, breast cancer, ovarian cancer and many others. 

18.1 million new cases of solid tumours per year (2018, WHO)
Official title:
A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors


Name: Angie Schinkel

Phone: 858-779-3103



United States, Colorado

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218


United States, California

University of California, San Diego, San Diego, California, United States, 92037

University of California, San Francisco, San Francisco, California, United States, 94143


United States, Kansas

University of Kansas Cancer Center, Westwood, Kansas, United States, 66205


United States, Texas

MD Anderson Cancer Center, Houston, Texas, United States, 77030

NEXT Oncology, San Antonio, Texas, United States, 78229


Study start:
Feb. 15, 2022
Gene editing method:
Type of edit:
Knock-out and knock-in
Major histocompatibility complex I (MHC-I) and T cell receptor (TCR-I)
Delivery method:
Non-viral piggyBac® DNA Delivery System used for CAR transgene insertion, and the Cas-CLOVER™ SiteSpecific Gene Editing System to knockout both the TCR and MHC class I proteins - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-MUC1C-ALLO1 to determine a Recommended Phase 2 Dose (RP2D). P-MUC1C-ALLO1 is an allogeneic chimeric antigen receptor (CAR)-T cell therapy designed to target cancer cells expressing Mucin1 cell surface associated C-Terminal (MUC1-C) antigen. Additional participants will be treated with P-MUC1C-ALLO1 at the determined RP2D.

Following enrollment, subjects will be treated with P-MUC1C-ALLO1 and will undergo serial measurements of safety, tolerability and response.

Last updated: Jun. 5, 2023
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