Status:
UNKNOWN
Engineered Immune Effectors Against Ovarian Cancer
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
10-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- 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
- 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 were negative.
Exclusion
- 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
- 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 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.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03362606
Start Date
November 15 2017
End Date
December 1 2020
Last Update
September 19 2019
Active Locations (3)
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1
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510415
2
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
3
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
Kunming, Yunnan, China, 650000