Genetically modified T cells for ovarian cancer
Innovative Treatment of Ovarian Cancer Based on Immunogene-modified T Cells (IgT)
This test tries infusions of a patient's own genetically modified T cells (OC-IgT) given into the bloodstream or directly into tumors to see if they are safe and help women with advanced ovarian cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | chemotherapy, CART, chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT03184753 on ClinicalTrials.gov |
What this trial studies
This phase 1/2 study uses autologous OC-IgT cells — a patient's own T cells engineered to target ovarian cancer — delivered by intravenous infusion or by direct injection into tumors. The primary endpoints focus on safety and tolerability of the infusions, while secondary endpoints include the success rate of manufacturing OC-IgT cells and measures of anti-tumor activity. Eligible participants are women aged 20 or older with high-risk epithelial ovarian cancer (FIGO stage III–IV), adequate organ function, and ECOG performance status 0–2. All treatment and follow-up are conducted at Shenzhen Geno-Immune Medical Institute, with close monitoring for immune-related and infusion-related toxicities.
Who should consider this trial
Good fit: Women aged 20 or older with histologically confirmed high-risk epithelial ovarian cancer (FIGO stage III–IV), ECOG 0–2, adequate blood, liver and kidney function, life expectancy ≥3 months, and the ability to undergo leukapheresis and travel to Shenzhen are ideal candidates.
Not a fit: Patients with non-epithelial ovarian tumors, inadequate organ function or blood counts, active pregnancy, poor performance status, or those who cannot provide sufficient T cells for manufacturing may not benefit from this therapy.
Why it matters
Potential benefit: If successful, OC-IgT therapy could offer a targeted immunotherapy that reduces tumor burden or extends remission for women with advanced ovarian cancer.
How similar studies have performed: CAR-T therapies have produced dramatic results in blood cancers but have shown limited and mixed success in solid tumors like ovarian cancer, so this approach remains experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written, informed consent obtained prior to any study-specific procedures. 2. Female patients ≥ 20 years. 3. 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. * Complete remission after salvage treatment for first recurrence. 7. 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 Criteria: 1.Patients with: * Non-epithelial ovarian cancer. * Ovarian tumors with low malignant potential (i.e. borderline tumors). * 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). * 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. 9\. 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.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Lung-Ji Chang, PhD — Shenzhen Geno-Immune Medical Institute
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: +86 0755-86573763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.