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SUSPENDEDPHASE1/PHASE2

Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors

Interventional Treatment of Ovarian Cancer With Cancer Antigen-specific Engineered Immune Effector T Lymphocytes (OC-EIEs)

NCT03393962•Shenzhen Geno-Immune Medical Institute

View on ClinicalTrials.gov

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.

Detailed Description

Ovarian cancer (OC) is a cancer that is derived from an ovary. The majority of OC arises from the epithelium (outer lining) of the ovary. In 2015, OC was found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women, OC is the seventh-most common cancer and the eighth-most common cause of cancer death. Treatment for OC consists of surgery, chemotherapy, immunotherapy and radiotherapy. The kind of treatment depends on many factors, including the type of OC, its stage and grade, as well as the general health of the patient. Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with tumor antigens has proven to be effective against many types of cancer. OC has been shown to be highly immunogenic and therefore may respond well to innovative antigen-specific immunotherapy. Here, through cancer antigen screening and careful target antigen evaluation, the investigation aims to evaluate the safety and efficacy of multiple infusions of OC antigen-specific, engineered immune effectors (EIEs) in patients with OC.

Eligibility

Age

10 - 80 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Written, informed consent obtained prior to any study-specific procedures.
•2. Age older than 10 years.
•3. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
•4. Expected survival ≥ 12 weeks.
•5. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV.
•6. Not pregnant, and on appropriate birth control of childbearing potential.
•7. Initial hematopoietic reconstitution with
•* neutrophils (ANC) ≥ 1,000/mm\^3;
•* platelet (PLT) ≥ 100,000/mm\^3.
•8. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
+6 more criteria

Exclusion Criteria

•1. Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
•2. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
•3. Prior treatment of any adoptive T cell therapy.
•4. Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive drug
•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 with
•* absolute neutrophil count \< 1,000/mm\^3;
•* platelet count \< 100,000/mm\^3;
•* Hb \< 9 g/dL.
+8 more criteria

Locations (3)

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Kunming, Yunnan, China

Key Dates

Start Date

December 1, 2017

Primary Completion Date

January 1, 2020

Completion Date

December 1, 2020

Last Updated

July 31, 2018

Enrollment

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

OC-EIEs

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors

Inclusion Criteria

Exclusion Criteria

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