How far is the clinical trial?

Disease: Metastatic epithelial-derived solid tumors (NCT05239143)

Q: What is the treatment for?

Read more here 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.

Q: Where does the clinical trial take place?

Read more here 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

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.

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:

Contact

Name: Angie Schinkel

Phone: 858-779-3103

Email: clinicaltrials@poseida.com

Sponsor:

Poseida Therapeutics

Partners:

Locations:

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

Enrollment:

100

Gene editing method:

Cas-CLOVER

Type of edit:

Knock-out and knock-in

Gene:

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

Trial link:

https://clinicaltrials.gov/ct2/show/NCT05239143

Safety updates:

(12-06-2022) Poseida Therapeutics to Present Early Data from Phase 1 Trials of P-MUC1C-ALLO1 and P-BCMA-ALLO1 at ESMO Immuno-Oncology 2022 Annual Congress

(20-12-2021) Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-MUC1C-ALLO1, a Fully Allogeneic CAR-T Targeting Multiple Solid Tumors

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: Jun. 5, 2023

Disease: Metastatic epithelial-derived solid tumors (NCT05239143)

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