Overview
This phase I/II trial aims to evaluate safety and efficacy of Chidamide, Decitabine and Immune checkpoint inhibitors in relapsed/refractory Non-Hodgkin Lymphoma and advanced solid tumors.
Description
Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. Low-dose decitabine inhibits the activity of DNA methyltransferase, which can increase the expression of tumor antigens and HLA molecules, enhance antigen processing, promote T cell infiltration, and boost effector T cell function. Immune checkpoint inhibitors (ICIs) have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells. In conclusion, we speculate that the chemotherapy free regimen of Chidamide, Decitabine and Immune checkpoint inhibitors may explore a new avenue for therapeutic intervention in relapsed/refractory Non-Hodgkin Lymphoma and advanced solid tumors.
Eligibility
Inclusion Criteria:
- 16 to 80 years of age.
- ECOG performance of less than 3.
- Life expectancy of at least 3 months.
- Histopathological confirmed Non-Hodgkin Lymphoma and solid tumors.
- Patients are relapsed/refractory Non-Hodgkin Lymphoma with ineligible for autologous hematopoietic stem cell transplantation.
- The guidelines（ASCO/CSCO）recommend patients to participate in clinical trials.
- Subjects must have at least one measureable target lesion.
- Willingness to provide written informed consent for the study.
Exclusion Criteria:
- Active, known or suspected autoimmune diseases.
- Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- History of severe hypersensitive reactions to other monoclonal antibodies.
- History of allergy or intolerance to study drug components.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function.
- Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
- History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented.
- Vaccination within 30 days of study enrollment.
- Active bleeding or known hemorrhagic tendency.