Overview
Neoantigen Reactive T Cells Combined With SHR-1210 for Chinese Patients With Advanced Refractory Solid Tumors
Status:
Unknown status
Unknown status
Trial end date:
2020-12-31
2020-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) combined with programmed cell death-1(PD-1) inhibitor(SHR-1210)in the treatment of Chinese patients with advanced refractory solid tumors.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolTreatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Interleukin-2
Criteria
Inclusion Criteria:- Adult patients aged 18 to 75 years old
- Histologic or cytologic confirmation of advanced refractory solid tumors with no
available curative treatment options
- At least one measurable disease: diameter ≥20mm or spiral computed
tomography(CT)≥10mm; and can providing with tumor specimen (for testing the expression
of PD -L1 and the infiltrating lymphocytes)
- Must be human leukocyte antigen (HLA)-A2/A24/A11 positive
- Eastern Cooperative Oncology Group(ECOG)<0-2 and expected survival time 3 months or
more
- At least one new antigen can induce T cell secrete interferon - gamma (IFN - gamma)
twice as normal controls during the new antigens screening
- Without anticancer treatment more than one month
- Hematology Index including: Neutrophile granulocyte greater than 1.5×10^9/L;
Hemoglobin greater than 10g/dL; Platelet greater than 100×10^9/L
- Biochemical index including: Serum bilirubin not greater than 1.5x upper limit of
reference range (ULN); glutamic-pyruvic transaminase(ALT) or glutamic-oxalacetic
transaminase(AST) not greater than 2.5x ULN; Creatinine clearance no less than
60ml/min
- Peripheral venous channel open and no contraindications to separating lymphocytes
- Negative pregnancy test for women of childbearing potential, and patients must be
willing to practice birth control during the regimen
- Provision of informed consent
- Be able to follow the research program and follow up process
Exclusion Criteria:
- Those who now are undergoing other antitumor drug therapy (including chemotherapy,
systemic steroids therapy, surgery, target therapy or immune therapy);
- Prior treatment with PD-1 monoclonal antibody(mAb) or PD-L1 mAb;
- Prior malignancy active within the previous 5 years except for locally curable cancers
that have been apparently cured, such as basal cell skin cancer or carcinoma in situ
of the cervix;
- History with pulmonary tuberculosis, and positive tests for Acquired Immune Deficiency
Syndrome(HIV),hepatitis C virus(HCV),hepatitis B virus(HBV);
- Patients with any active autoimmune disease or a documented history of autoimmune
disease, or history of syndrome that required systemic steroids or immunosuppressive
medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis,
hyperthyroidism or hypothyroidism; Severe, uncontrolled medical condition that would
affect patients' compliance or obscure the interpretation of toxicity determination or
adverse events, including active severe infection, uncontrolled diabetes,
angiocardiopathy (heart failure > class II New York Heart Association(NYHA), heart
block >II grade, myocardial infarction, unstable arrhythmia or unstable angina within
past 6 months, cerebral infarction within past 3 months) or pulmonary disease (
interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm).
- Evidence with central nervous system(CNS) disease
- Pregnant or nursing
- Psychiatric medicines abuse without withdrawal, or history of psychiatric illness.
- Hypersensitivity to investigational drugs or its components.