Clinical Trial

Disease: Solid Tumors, (NCT05239143)

Disease info:

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Solid tumour types are named according to the type of cell they originate from. Examples of solid tumours include sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours. 

The word tumor does not always imply cancer. In discussing tumors that are malignant (cancerous), however, the term solid tumor is used to distinguish between a localized mass of tissue and leukemia.

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:
More than 1.9 million new cancer cases are expected to be diagnosed in the US in 2023.
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

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
IndicatorIndicator
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: Apr. 11, 2024
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