Clinical Trial

Disease: Epithelial Ovarian Cancer, EOC, (NCT05617755)

Disease info:

Ovarian cancer is a non-specific term that refers to cancer that arises in the female reproductive organ known as the ovaries. Epithelial ovarian cancer (EOC) is a specific form of ovarian cancer that arises from epithelial cells and accounts for over 90% of ovarian cancer. Epithelial cells are a thin layer of cells that cover most internal and external surfaces of the body and organs. EOC often refers to epithelial cancer of the ovaries, fallopian tubes, and peritoneum as these all share common characteristics. Research suggests that many of these cancers begin at the epithelial cells of the fallopian tubes and cancer cells migrate to the ovaries.

Over half of all ovarian cancers involve somatic mutations in the TP53 gene.

Germline mutations in BRCA1 and BRCA2 genes are involved in approximately 20% of ovarian cancers.

Due to commonly late diagnosis, ovarian cancer can be hard to treat. When diagnosed early the 5-year survival rate is high. Treatment included surgeries to remove cancerous tissue, chemotherapy to shrink or kill the cancer and targeted therapies to specifically kill cancer cells to stop or slow the tumour spread growth.

Frequency:
Ovarian cancer is diagnosed in approximately 22,000 women in the United States each year.
Official title:
An Open-label Phase 1 Study to Evaluate the Safety and Efficacy of AB-1015 in Patients With Resistant/Refractory Epithelial Ovarian Cancer
Who:

Contact: Arsenal Biosciences

Phone: 650-212-5368

Email: clinicaltrials@arsenalbio.com
 

Partners:
Locations:

United States, California

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States, 94158

 

United States, Iowa

U. of Iowa Health Care, Iowa City, Iowa, United States, 52242

 

United States, Michigan

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

 

United States, New York

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14203

 

United States, Texas

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

Study start:
Nov. 29, 2022
Enrollment:
60 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene insertion
Gene:
Insertion of a large synthetic double-stranded DNA cassette into a novel Chromosome 11 safe harbour site. The cassette encodes a synthetic logic gate designed to optimise how the ICT cells target tumours & avoid normal tissues by requiring the co-expression of two distinct antigens within ovarian cancer, and a module containing synthetic short hairpin RNAs designed to pharmacologically modulate gene expression to enable enhanced T cell function in the tumour microenvironment.
Delivery method:
Electroporation - Ex-vivo
Note:
AB-1015 is an autologous, integrated circuit T cell (ICT) product.
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This study is intended for the patients who have been diagnosed with Epithelial Ovarian Cancer that either came back or did not improve after platinum treatments (platinum resistant). The purpose of this study is to test the safety of using a new treatment called Integrated Circuit T (ICT) cells (AB-1015 cells) in patients with ovarian cancer. This treatment has not been approved by the Food and Drug Administration.

The goal of this study is to calculate the maximum tolerated dose of the AB-1015 cells. T cells are part of the immune system that protect the body from infection and may help fight cancer. The T cells given in this study will come from the patient and will have a genetic circuit/logic gate put in them that makes them able to recognize alkaline phosphatase, germ line/placental (ALPG/P) and mesothelin (MSLN), 2 proteins on the surface of tumor cells. These logic-gated T cells may help the body's immune system identify and kill cancer cells while sparing normal healthy tissues from toxicity.

The AB-1015 cells are given intravenously, after completing 3 rounds of conditioning chemotherapy administered over 3 consecutive days. Conditioning chemotherapy prepares the body to receive the AB-1015 cells. If they continue to meet the eligibility criteria, AB-1015 cells will be given to them 2 days after the last conditioning chemotherapy round. A single infusion of the AB-1015 cells will be given to the subject intravenously.

After completion of study treatment, patients are followed with serial measurements of safety, tolerability and response.

This is a research study to obtain new information that may help people in the future.

Last updated: Jan. 23, 2024
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