Actively Recruiting
Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-04-24
100
Participants Needed
3
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE).
CONDITIONS
Official Title
Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any study procedures.
- Immune staining of patient's tumor positive for one or more tumor-associated antigens such as GD2, mesothelin, P16, MMP, Melan A, MAGE A1, MAGE A3, or MAGE A4.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Life expectancy of at least 3 months.
- Ability to comply with the study protocol.
- Histologically confirmed high risk International Federation of Gynecology and Obstetrics (FIGO) Stage III-IV.
- Not pregnant and using appropriate birth control if of childbearing potential.
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1000/mm3 and platelets ≥ 100,000/mm3.
- Adequate kidney and liver function: serum creatinine ≤ 2 times upper limit of normal (ULN), bilirubin ≤ 2 times ULN (2.0 acceptable with Gilbert's syndrome), AST/ALT ≤ 2 times ULN, alkaline phosphatase ≤ 5 times ULN.
You will not qualify if you...
- Immune staining of all patient's tumor-associated antigens negative.
- Previous experience with other cell therapies.
- Participation in other cell therapy protocols within the past year.
- Current or recent treatment with another investigational drug within 28 days before Day 0.
- Minor surgery within 2 days before Day 0, including device placement or tumor biopsies.
- Pregnant or breastfeeding females.
- Unable to comply with study requirements.
- Inadequate bone marrow function: ANC < 1.0 x 10e9/L, platelets < 100 x 10e9/L, hemoglobin < 9 g/dL.
- Inadequate liver and kidney function: bilirubin > 1.5 x ULN, AST/ALT > 2.5 x ULN (> 5 x ULN with liver metastases), alkaline phosphatase > 2.5 x ULN (or higher with metastases), serum creatinine > 2.0 mg/dl.
- Proteinuria ≥ 2+ on dipstick urinalysis without confirmation of less than 1 g/24 hr protein.
- Serious active infection requiring intravenous antibiotics during screening.
- Infection with HIV, Treponema pallidum antibody positive, or positive tuberculosis culture.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
QiFu Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510415
Actively Recruiting
2
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
3
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
Kunming, Yunnan, China, 650000
Actively Recruiting
Research Team
L
Lung-Ji Chang, PhD
CONTACT
Y
Yichun Cai, MD
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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