Status:
UNKNOWN
Engineered Immune Effectors Against Cervical Cancer
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Cervical Cancer
Eligibility:
FEMALE
10-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to evaluate the safety of cervical cancer specific engineered immune effectors (CC-EIEs). The secondary objectives are to evaluate the rate of successful CC-EIE ...
Detailed Description
Cervical cancer (CC) is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of the cases. Other risk factors include smoking, a weak immune system, birth contro...
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.
- Not pregnant, and on appropriate birth control if of childbearing potential.
- Evidence of high-risk HPV infection.
- Stage III-IV or recurrent cervical cancer.
- 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 negative.
Exclusion
- Patients with
- cervical benign lesions: cervical columnar epithelium ectopic, cervical polyps, cervical endometriosis and cervical tuberculous ulcers;
- cervical benign tumors: cervical submucous myoma, cervical cancer, cervical papilloma.
- Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
- Previous exposure to mouse SCC antibody.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
- 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 actively infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV 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
NCT03362619
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