Genetically Modified T Cells Against Ovarian Cancer

Trial details

Who runs it

Shenzhen Geno-Immune Medical Institute

Trial code

NCT03184753

Record updated

3 November 2026

Original description

The primary objectives are to evaluate the safety and efficacy of infusion of autologous ovarian cancer immunogene-modified T cells (OC-IgT cells).Read full original descriptionShow less

Innovative Treatment of Ovarian Cancer Based on Immunogene-modified T Cells (IgT)

The primary objectives are to evaluate the safety and efficacy of infusion of autologous ovarian cancer immunogene-modified T cells (OC-IgT cells).

Inclusion: Written, informed consent obtained prior to any study-specific procedures; Female patients ≥ 20 years; Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2; Life expectancy ≥ 3 months; Able to comply with the protocol; Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV; Complete remission after salvage treatment for first recurrence; Not pregnant, and on appropriate birth control if of childbearing potential; Adequate bone marrow reserve with ·absolute neutrophil count (ANC) ≥ 1000/mm3; ·Platelets ≥100,000/mm3; 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: Non-epithelial ovarian cancer; Ovarian tumors with low malignant potential (i.e. borderline tumors); 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 at during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive; Synchronous primary endometrial carcinoma and ovarian cancer. 2.Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment); Previous experience of gene-engineered T cell therapy 4.Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study; 5.Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations); 6.Pregnant or lactating females. 7.Inadequate bone marrow function:; ·Absolute neutrophil count < 1.0 x 109/L; Platelet count < 100 x 109/L; Hb < 9 g/dL. 8. 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); 1.Patients with:.

ClinicalTrials.gov NCT03184753