Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific Immune Effectors (EIEs)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- Shenzhen Geno-Immune Medical Institute
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Safety of CC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
- Last Updated
- 6 years ago
Overview
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 generation in vitro and determine the anti-CC efficacy.
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 control pills, starting sex at a young age, and having many sexual partners, but these are less important. Worldwide, CC is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of CC consists of surgical intervention, radiation, chemotherapy and immunotherapy. Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of CC-specific engineered immune effectors including cytotoxic T lymphocytes in patients.
Investigators
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute
Eligibility Criteria
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
- •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\^
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Safety of CC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Time Frame: 6 months
Physiological parameter (measuring cytokine response, fever, symptoms)
Secondary Outcomes
- Functional analyses of CC-EIEs in vitro(4 weeks)
- Anti-tumor effects(1 year)