Actively Recruiting
Immunotherapy Treating GI Cancer
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-04-24
100
Participants Needed
1
Research Sites
182 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 gastro-intestinal (GI) cancer antigen-specific engineered immune effector cells (EIE).
CONDITIONS
Official Title
Immunotherapy Treating GI Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written, informed consent obtained prior to any study-specific procedures.
- Positive immune staining of patient cancer specimens for one or more tumor-associated antigens such as GD2, mesothelin, CEA, 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.
- Able to comply with the study protocol.
- Histologically confirmed and documented 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 with absolute neutrophil count (ANC) of at least 1000/mm3 and platelets at least 100,000/mm3.
- Adequate kidney and liver function with serum creatinine no greater than twice the upper limit of normal (ULN), serum bilirubin no greater than twice ULN (bilirubin up to 2.0 acceptable with Gilbert's syndrome), AST/ALT no greater than twice ULN, and alkaline phosphatase no greater than five times ULN.
You will not qualify if you...
- Immune staining of tumor-associated antigens is negative.
- Participation in any other cell therapy protocols within the past year.
- Treatment with another investigational drug within 28 days prior to Day 0.
- Minor surgery within 2 days prior to Day 0 including procedures like central venous access device placement or tumor biopsies.
- Pregnant or lactating females.
- Unable to comply with trial requirements.
- Inadequate bone marrow function: absolute neutrophil count less than 1.0 x 10^9/L, platelet count less than 100 x 10^9/L, or hemoglobin less than 9 g/dL.
- Inadequate liver and kidney function: serum bilirubin over 1.5 times ULN, AST and ALT over 2.5 times ULN (or over 5 times ULN if liver metastases), alkaline phosphatase over 2.5 times ULN (or higher with metastases), serum creatinine over 2.0 mg/dL.
- Proteinuria of 2+ or greater on dipstick urinalysis without confirmation of less than 1 g protein in 24-hour urine.
- Serious active infection requiring intravenous antibiotics during screening.
- Infection with HIV, Treponema pallidum antibody positive, or positive tuberculosis culture.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
Lung-Ji Chang, 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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