Engineered immune cells take aim at Hard-to-Treat cervical cancer
NCT ID NCT03356795
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This trial investigates whether specially engineered immune cells (CAR-T cells) can safely treat advanced or recurrent cervical cancer. The cells are designed to recognize and attack cancer cells that carry certain markers like GD2 or Mesothelin. The study involves 20 adults with stage III, IV, or relapsed cervical cancer and will monitor side effects, tumor response, and how long the modified cells last in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-T cells targeting GD2, PSMA, Muc1, or Mesothelin
- What this could lead to
- If successful, this approach could offer a new treatment option for advanced cervical cancer that has not responded to standard therapies.
- What could go wrong
- This is an early-phase trial with only 20 participants, so results may not apply broadly. CAR-T therapy can cause severe 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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18 to 70 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. Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy. 2. Age: ≥ 18 years and ≤ 70 years. 3. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy. 4. Side Effects of Chemotherapy have subsided. 5. GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry. 6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 7. Expected survival ≥ 12 weeks. 8. Initial hematopoietic reconstitution with * neutrophils (ANC) ≥ 1×10\^6/L; * platelet (PLT) ≥ 1×10\^8/L. 9. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with * serum creatinine ≤ 2×ULN; * serum bilirubin ≤ 3×ULN; * AST/ALT ≤ 2.5×ULN. 10. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures. Exclusion Criteria: 1. Airway obstruction caused by tumor. 2. History of epilepsy or other central nervous system diseases. 3. Patients who require systemic corticosteroid or other immunosuppressive therapy. 4. History of prolonged or serious heart disease during QT. 5. history of serious cyclophosphamide toxicity. 6. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. 7. Inadequate liver and renal function with * serum creatinine \> 1.5 mg/dl; * serum (total) bilirubin \> 2.0 mg/dl; * AST \& ALT \> 3 x ULN. 8. Pregnant or lactating females. 9. Serious active infection during screening. 10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection. 11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
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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
-
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
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Other studies related to the condition(s) this trial covers.
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