Clinical Trial

Disease: Ovarian Cancer, OC, (NCT06846424)

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:
An estimated 20,890 women will be diagnosed with ovarian cancer in 2025.
Official title:
A Clinical Study to Evaluate the Safety and Tolerability of SCT-001 CAR-T Cells in Patients with Recurrent and Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Peritoneal Cancer.
Who:

Contact

Name: Rongyu Zang Doctor

Email: zang.rongyu@zs-hospital.sh.cn

Sponsor:

Shanghai Gynecologic Oncology Group

Partners:
Locations:

Shanghai Municipality, China

Zhongshan Hospital Fudan University, Shanghai, Shanghai Municipality, China, 200032

Study start:
Jun. 1, 2025
Enrollment:
24 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knockout
Gene:
Immunosuppressive related genes
Delivery method:
- Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

This study is an open-label, dose-escalation, investigator-initiated phase I interventional clinical study. To evaluate the safety, tolerability and preliminary efficacy of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer, and to explore the pharmacokinetic characteristics, biomarker changes and immunogenicity of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer.

In this study, two trial cohorts were set up, cohort 1 was the intraperitoneal route of administration, and the subjects enrolled in cohort 1 needed to meet the conditions for intraperitoneal administration ((1) the subject had a large amount of ascites, (2) the subject was suitable for peritoneal catheterization, (3) the subject had no severe abdominal adhesions, and (4) the subject agreed to undergo intraperitoneal surgical catheterization for intraperitoneal administration); Cohort 2 is the intravenous route.

Last updated: Sep. 18, 2025
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