Clinical Trial

Disease: Solid Tumors, (NCT03970382)

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 are sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours.

The word tumour does not always imply cancer. In discussing tumours that are malignant (cancerous), however, the term solid tumour is used to distinguish between a localised mass of tissue and leukaemia.

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.
 

Frequency:
Excluding non-melanoma skin cancers, over 2 million new cancer cases are expected to be diagnosed in the US in 2025.
Official title:
A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors
Who:
Sponsor:

PACT Pharma, Inc.

Partners:
Locations:

United States, California

City of Hope
Duarte, California, United States, 91010

University of California, Los Angeles
Los Angeles, California, United States, 90024

University of California, Irvine Medical Center
Orange, California, United States, 92868

University of California, Davis
Sacramento, California, United States, 95817

University of California, San Francisco
San Francisco, California, United States, 94158

United States, Illinois

Northwestern University Medical Center
Chicago, Illinois, United States, 60611

United States, New York

Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

United States, Tennessee

Tennessee Oncology
Nashville, Tennessee, United States, 37203

United States, Washington

Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109

Study start:
Jul. 3, 2019
Enrollment:
21 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out and insertion
Gene:
Knock-out of TCRα (TRAC) and TCRβ (TRBC) genes, and insertion of genes encoding the two chains of a neoantigen-specific TCR (neoTCR) in in the TRAC locus .
Delivery method:
Non-viral - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/NCT03970382
Safety updates:

(11-10-2022) Company press release: PACT Pharma Reports Data From First Clinical Study Using CRISPR to Substitute a Gene in Patients' Immune Cells to Treat Cancer

(10-10-2022)  Foy SP, Jacoby K, Bota DA, et al. Non-viral precision T cell receptor replacement for personalized cell therapy [published online ahead of print, 2022 Nov 10]. Nature. 2022;10.1038/s41586-022-05531-1. doi:10.1038/s41586-022-05531-1

 

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Suspended

Description

This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.

The investigational agent in this protocol is NeoTCR P1, an autologous adoptive T cell therapy (ACT) for patients with solid cancer. NeoTCR P1 is composed of apheresis derived CD8 and CD4 T cells that are precision genome engineered to express one autologous TCR of native sequence that targets a neoepitope (neoE) presented by human leukocyte antigen (HLA) receptors exclusively on the surface of that patient's tumor cells and not on other cells in the body.

Last updated: May. 20, 2025
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