Tests engineered immune cells against gastrointestinal cancer
Tests patient-derived engineered immune cells in people with gastrointestinal cancer.
Plain-language title generated from the registry record
Registry title: Immunotherapy Treating GI Cancer
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 80 years old?
Source: NCT03614650, who can take part
Where in China
- Shenzhen Geno-immune Medical InstituteShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Geno-Immune Medical Institute
- Trial code
- NCT03614650
- Record updated
- 2 November 2026
- Original description
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).Read full original descriptionShow less
Antigen-specific Engineered Immune Effector Cells (EIE) Against Gastro-Intestinal (GI) Cancer
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).
Inclusion: 1. Written, informed consent obtained prior to any study-specific procedures. 2. The results of immune staining of the patient's cancer specimens positive for any one or more of tumor-associated antigens, such as GD2, mesothelin, CEA, P16, MMP, Melan A, MAGE A1, MAGE A3, and MAGE A4; Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. 4. Life expectancy ≥ 3 months. 5. Able to comply with the protocol. 6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV; Not pregnant, and on appropriate birth control if of childbearing potential. 8. Adequate bone marrow reserve with; absolute neutrophil count (ANC) ≥ 1000/mm3.• Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with• Serum creatinine ≤ 2 x upper limit of normal (ULN).• Serum bilirubin ≤ 2 x ULN.• aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.• Alkaline phosphatase ≤ 5 x ULN.• Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
Exclusion: Urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr; Serious active infection requiring i.v. antibiotics during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive; 1. The results of immune staining of the patient's tumor-associated antigens are all negative; Participation in any other cell therapy protocols within one year. 3. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug; Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations); Pregnant or lactating females. 6. Unable to comply with the trial related requirement. 7. Inadequate bone marrow function:; Absolute neutrophil count < 1.0 x 10e9/L; Platelet count < 100 x 10e9/L; Hb < 9 g/dL; Inadequate liver and renal function:; Serum (total) bilirubin > 1.5 x ULN.• AST \& ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases); Alkaline phosphatase > 2.5 x ULN (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases); Serum creatinine >2.0 mg/dl (> 177 μmol/L).