Engineered Immune Effectors Against Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CC-EIEs.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 10 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific Immune Effectors (EIEs)
Overview
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.
Interventions
- Biological CC-EIEs
2 to 4 infusions, once a week, for 1x10\^5\~1x10\^7 CTLs/kg via IV, abdominal cavity or intratumoral injection each time
Primary outcome measures
- Safety of CC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [Time frame: 6 months]
Secondary outcome measures (2)
- Functional analyses of CC-EIEs in vitro [Time frame: 4 weeks]
- Anti-tumor effects [Time frame: 1 year]
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 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 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen Geno-immune Medical Institute — Shenzhen
Identifiers
NCT: NCT03362619 · GIMI-IRB-17019