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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
2 to 4 infusions, once a week, 0.1\~4x10\^6 CTLs/kg; injection via IV, abdominal cavity or intrastumoral.
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China
Safety of OC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
percentage of patients with grade 3 or above adverse effect
Time frame: 6 months
Expansion of OC-EIEs
The increased fold of specificity of OC-EIEs, will be analyzed by enzyme-linked immunospot assay (ELISPOT)
Time frame: 8 weeks.
percentage of complete response
Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame: 1 year
percentage of partial response
Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame: 1 year
percentage of stable disease
Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame: 1 year
percentage of progressive disease
Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame: 1 year
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