Intervention of CAR-T Against Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cervical cancer-specific CAR-T cells.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Trial of Chimeric Antigen Receptor-Modified T Cells (CAR-T Cells) in the Treatment of Cervical Cancer
Overview
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.
Detailed description
Cervical cancer is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of cases. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Worldwide, cervical cancer is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of cervical cancer consists of surgical intervention, radiation, chemotherapy and immunotherapy.
In this study, the participant's T-cells will be collected and modified. Then the modified T cells, called chimeric antigen receptor modified-T cells (CAR T) which can recognize specific molecules that are expressed on the surface of cervical cancer cells, are given back to the participant by intravenous infusion.
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.
Interventions
- Biological Cervical cancer-specific CAR-T cells
1 infusion, for 1x10\^6\~1x10\^7 cells/kg via IV
Primary outcome measures
- Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [Time frame: 3 months]
Secondary outcome measures (2)
- Persistence and proliferation of CART cells in patients [Time frame: 3 months]
- Anti-tumor effects [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen Geno-immune Medical Institute — Shenzhen
Identifiers
NCT: NCT03356795 · GIMI-IRB-17017