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This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer specific cytotoxic lymphocytes (OC-CTLs) in women.
Ovarian cancer is a cancer that forms in or on an ovary. The majority of ovarian cancers arise from the epithelium (outer lining) of the ovary. In 2015 it was reported found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women it is the seventh-most common cancer and the eighth-most common cause of death from cancer. Treatment for ovarian cancer consists of surgery, chemotherapy, immunotherapy and sometimes, radiotherapy. The kind of treatment depends on many factors, including the type of ovarian cancer, its stage and grade, as well as the general health of the patient.
Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of ovarian cancer specific cytotoxic T lymphocytes in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC-CTLs | Experimental | Autologous ovarian cancer specific cytotoxic lymphocytes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC-CTLs | Biological | 2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg via IV, abdominal cavity or tumor injection each time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of OC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events | Physiological parameter (measuring cytokine response, fever, symptoms) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional analyses of OC-CTLs in vitro | The specificity of OC-CTLs in vitro will be analysed by enzyme-linked immunospot assay (ELISPOT). | 4 weeks |
| Anti-tumor effects | Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. |
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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 if of childbearing potential.
Initial hematopoietic reconstitution with
Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative.
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).
Previous treatment of adoptive T cell therapy.
Current or recent treatment (within the 28-day period prior to Day 0) with another investigational 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
Serious active infection requiring i.v. antibiotics at during screening.
Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), and HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lung-Ji Chang, PhD | Contact | +86 0755-86573763 | c@szgimi.org |
| Name | Affiliation | Role |
|---|---|---|
| Lung-Ji Chang, PhD | Shenzhen Geno-Immune Medical Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Geno-immune Medical Institute | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| 1 year |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |