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.
Company
Poseida Therapeutics
Disease: Metastatic epithelial-derived solid tumors (NCT05239143)
Disease info:
Frequency:
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
Who:
Angie Schinkel, 858-779-3103, clinicaltrials@poseida.com
Sponsor:
Partners:
None
Locations:
United States, Colorado
United States, California
United States, Kansas
United States, Texas
Study start:
Feb. 15, 2022
Enrollment:
100
Gene editing method:
Cas-CLOVER
Type of edit:
Knock-out
Gene:
Major histocompatibility complex I (MHC-I) and T cell receptor (TCR)
Delivery method:
Undsiclosed - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy
Status: Active recruiting
Description
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: Jan. 2, 2023