Status:
UNKNOWN
Intervention of CAR-T Against Cervical Cancer
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ca...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03356795
Start Date
November 15 2017
End Date
December 1 2020
Last Update
September 19 2019
Active Locations (1)
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1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000