Clinical Trial

Disease: Ovarian Cancer, OC, (NCT07067255)

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:
Phase 1/2 Study of Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer
Who:

Contact 

Name: Rhoda M Smith, Phd

Phone: +12077706670

Email: clinical-trials@essen-biotech.com

Sponsor:

Essen Biotech

Partners:
Locations:

China. Beijing

District One Hospital, Beijing, Beijing, China, 086-373

Study start:
Apr. 29, 2025
Enrollment:
80 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene insertion
Gene:
CD146 and GPC3-targeting CAR genes
Delivery method:
- 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 a multicenter, open-label Phase 1/2 clinical trial evaluating the safety and preliminary efficacy of sequentially administered CD146-targeted and GPC3-targeted CAR-T cell therapy in patients with advanced relapsed or refractory ovarian cancer. Eligible patients will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of autologous CD146-directed CAR-T cells (Arm A) and a subsequent infusion of autologous GPC3-directed CAR-T cells (Arm B). The Phase 1 portion will assess safety, tolerability, and dose-limiting toxicities (DLTs) to determine a recommended Phase 2 dose, while the Phase 2 portion will evaluate efficacy endpoints including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Patients will be followed for up to 36 months after CAR-T infusion to monitor long-term outcomes and adverse events.

Last updated: Aug. 2, 2025
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