NCT03362619 Engineered Immune Effectors Against Cervical Cancer
| NCT ID | NCT03362619 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-06-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Written, informed consent obtained prior to any study-specific procedures. 2. Age older than 10 years. 3. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 4. Expected survival ≥ 12 weeks. 5. Not pregnant, and on appropriate birth control if of childbearing potential. 6. Evidence of high-risk HPV infection. 7. Stage III-IV or recurrent cervical cancer. 8. Initial hematopoietic reconstitution with * neutrophils (ANC) ≥ 1,000/mm\^3; * platelet (PLT) ≥ 100,000/mm\^3. 9. 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. 10. Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test negative. Exclusion Criteria: 1. 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. 2. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment). 3. Previous exposure to mouse SCC antibody. 4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. 5. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations). 6. Pregnant or lactating females. 7. Inadequate bone marrow function with * absolute neutrophil count \< 1,000/mm\^3; * platelet count \< 100,000/mm\^3; * Hb \< 9 g/dL. 8. 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. 9. Serious active infection requiring i.v. antibiotics at during screening. 10. 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.
Contact & Investigator
Lung-Ji Chang, PhD
PRINCIPAL INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Frequently Asked Questions
Who can join the NCT03362619 clinical trial?
This trial is open to female participants only, aged 10 Years or older, up to 80 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03362619 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03362619 currently recruiting?
Yes, NCT03362619 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT03362619 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT03362619 clinical trial?
NCT03362619 is sponsored by Shenzhen Geno-Immune Medical Institute. The principal investigator is Lung-Ji Chang, PhD at Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 20 participants.
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