RecruitingPhase 1Phase 2NCT03362619

Engineered Immune Effectors Against Cervical Cancer

Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific Immune Effectors (EIEs)

Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

20 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer

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.

Eligibility

Sex: FEMALEMin Age: 10 YearsMax Age: 80 Years

Inclusion Criteria17

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 Criteria20

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.