Engineered immune cells take on Hard-to-Treat cervical cancer
NCT ID NCT03362619
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This study tests a new treatment for people with advanced or recurrent cervical cancer linked to high-risk HPV. The treatment uses specially engineered immune cells (CC-EIEs) designed to target and attack the cancer. Participants receive several infusions of these cells, and researchers monitor safety and whether the tumors shrink or stabilize.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered immune cells (CC-EIEs)
- What this could lead to
- If successful, this approach could offer a new treatment option for advanced or recurrent cervical cancer that is hard to treat with standard therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the treatment may not work or could cause significant side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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20 people
The number who actually took part.
- Started
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Jun 2026
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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