Intervention of CAR-T Against Cervical Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Cervical Cancer

In brief

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

Key facts

Study ID

NCT03356795

Run by

Shenzhen Geno-Immune Medical Institute

People needed

20

Starts

2026-06-01

Expected to finish

2030-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy.
• Age: ≥ 18 years and ≤ 70 years.
• 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
• Side Effects of Chemotherapy have subsided.
• GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Expected survival ≥ 12 weeks.
• Initial hematopoietic reconstitution with
• neutrophils (ANC) ≥ 1×10\^6/L;
• platelet (PLT) ≥ 1×10\^8/L.
• 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.
• Oxygen saturation ≥ 90%.
• Written, informed consent obtained prior to any study-specific procedures.

You may not qualify if…

• Airway obstruction caused by tumor.
• History of epilepsy or other central nervous system diseases.
• Patients who require systemic corticosteroid or other immunosuppressive therapy.
• History of prolonged or serious heart disease during QT.
• history of serious cyclophosphamide toxicity.
• Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
• Inadequate liver and renal function with
• serum creatinine > 1.5 mg/dl;
• serum (total) bilirubin > 2.0 mg/dl;
• AST \& ALT > 3 x ULN.
• Pregnant or lactating females.
• Serious active infection during screening.
• Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
• Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Where it is running

• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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