Overview

Neoantigen Reactive T Cells Combined With SHR-1210 for Chinese Patients With Advanced Refractory Solid Tumors

Status:
Unknown status
Trial end date:
2020-12-31
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Treatments:
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.