NCT03356795TerminatedPhase 1/2
Intervention of CAR-T Against Cervical Cancer
Multicenter Trial of Chimeric Antigen Receptor-Modified T Cells (CAR-T Cells) in the Treatment of Cervical Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 24 Nov 2017
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Diseases
- Cervical cancer
- NCT number
- NCT03356795
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who require systemic corticosteroid or other immunosuppressive therapy.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
Other illness
- History of epilepsy or other central nervous system diseases.
- history of serious cyclophosphamide toxicity.
- Serious active infection during screening.
- Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
Lab values
- History of prolonged or serious heart disease during QT.
- Inadequate liver and renal function with
- serum creatinine > 1.5 mg/dl;
- serum (total) bilirubin > 2.0 mg/dl;
- AST \& ALT > 3 x ULN.
Other
- Airway obstruction caused by tumor.
- Pregnant or lactating females.
- Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen Geno-immune Medical Institute | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.