NCT05320640

Study of Chidamide, Decitabine and Immune Checkpoint Inhibitors in R/R NHL and Advanced Solid Tumors

A PhaseⅠ/Ⅱ Trial of Chidamide，Decitabine and Immune Checkpoint Inhibitors in Relapsed/Refractory Non-Hodgkin Lymphoma and Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Relapsed/Refractory Non-Hodgkin Lymphoma
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Chidamide	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.
DRUG	Decitabine	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.
DRUG	Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies）	Immune checkpoint inhibitors (ICIs) have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells.

Timeline

• Start date: 2022-03-30
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2022-04-11
• Last updated: 2022-04-11

Locations

1 site across 1 country: China