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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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 tumor antigens and HLA expression, 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.
Biotherapeutic Department, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective response rate (ORR)
The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: 3 years
Adverse events
Incidence, nature, and severity of adverse events are graded according to the National Cancer Institute Common Terminology Criteria for adverse events (version5.0).
Time frame: 3 years
Duration of response (DOR)
Time from the first recording of CR or PR evidence to disease progression or death from any cause was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: 3 years
Progression-free survival (PFS)
Time from the date of first administration of the study drug to disease progression or death from any cause.
Time frame: 3 years
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