Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors

Enrolling by invitation · Phase 1/Phase 2

Conditions studied: Ovarian Cancer

In brief

This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer-specific, engineered immune effectors (OC-EIEs) in women.

Key facts

Study ID

NCT03393962

Run by

Shenzhen Geno-Immune Medical Institute

People needed

20

Starts

2025-12-01

Expected to finish

2028-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 10 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Written, informed consent obtained prior to any study-specific procedures.
• Age older than 10 years.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Expected survival ≥ 12 weeks.
• Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV.
• Not pregnant, and on appropriate birth control of childbearing potential.
• Initial hematopoietic reconstitution with
• neutrophils (ANC) ≥ 1,000/mm\^3;
• platelet (PLT) ≥ 100,000/mm\^3.
• Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
• serum creatinine ≤ 2×ULN;
• serum bilirubin ≤ 2×ULN;
• AST/ALT ≤ 2×ULN;
• ALKP ≤ 5×ULN;
• serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
• Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) test negative.

You may not qualify if…

• Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
• Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
• Prior treatment of any adoptive T cell therapy.
• Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive 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.
• Inadequate bone marrow function with
• absolute neutrophil count < 1,000/mm\^3;
• platelet count < 100,000/mm\^3;
• Hb < 9 g/dL.
• Inadequate liver and renal function with
• 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;
• 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.
• Serious active infection requiring i.v. antibiotics
• Subject infected with HCV (HCV antibody positive), or HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.

Where it is running

• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China

Full record on ClinicalTrials.gov

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