By InvitationPhase 1/2

Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors

China20 participantsStarted 2025-12-01

Plain-language summary

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.

Who can participate

Age range10 Years – 80 Years

SexFEMALE

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Inclusion criteria

✓. 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
✓. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with

Exclusion criteria

✕. 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
✕. Inadequate liver and renal function with

What they're measuring

Safety of OC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

Timeframe: 6 months

Trial details

NCT IDNCT03393962

SponsorShenzhen Geno-Immune Medical Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-31

View on ClinicalTrials.gov More Ovarian Cancer trials