Actively Recruiting
Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer
Led by Essen Biotech · Updated on 2025-07-16
80
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expected survival time of 3 months or more
- Histologically or cytologically confirmed epithelial ovarian carcinoma that is relapsed or refractory
- Progression after at least one line of platinum-based chemotherapy or platinum-resistant
- Tumor positive for both CD146 and GPC3 by immunohistochemistry
- Measurable disease by RECIST 1.1 criteria
- Adults aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and bone marrow function including minimum counts and acceptable liver and kidney function
- Ability to understand and sign informed consent
- Women of child-bearing potential must have a negative pregnancy test and agree to use effective contraception
You will not qualify if you...
- Prior treatment with any CAR-T or gene-engineered T-cell therapy targeting CD146 or GPC3
- Active central nervous system metastases or carcinomatous meningitis
- Uncontrolled serious illnesses such as active infection or significant heart problems
- Active hepatitis B or C infection with viremia or uncontrolled HIV infection
- Need for chronic systemic immunosuppressive therapy except physiologic steroids
- Pregnant or breastfeeding women or unwillingness to use contraception
- Presence of another active malignancy requiring treatment
- Known severe allergy to study drugs or CAR-T cell components
- Any condition making the patient unsuitable for the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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