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

NCT05320640 | Unknown Phase 1 DMC

• 1 other identifier: CHN-PLAGH-BT-069
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed/Refractory Non-Hodgkin Lymphoma; Advanced Solid Tumors

Keywords

Relapsed/Refractory Non-Hodgkin Lymphoma; Advanced Solid Tumors; Chidamide; Decitabine; Immune Checkpoint Inhibitors; Chemotherapy free regimen

Outcome Measures

Primary Outcomes (2)

• Objective 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).

  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).

  3 years

Secondary Outcomes (2)

• Duration of response (DOR)

  3 years

• Progression-free survival (PFS)

  3 years

Other Outcomes (1)

• Biomarkers predictive of response

  3 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

Drug: Chidamide10mg/day, day1-4; 20mg/day, day8, 11, 15, 18. Drug: Decitabine10mg/day, day1-5. Drug: Immune Checkpoint Inhibitors（anti-PD1/PD-L1/CTLA4 antibodies）. Physicians will decide which ICIs will be used during treatment. Every 3 weeks.

Drug: Chidamide; Drug: Decitabine; Drug: Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies）

Interventions

Chidamide DRUG

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.

Experimental arm

Decitabine DRUG

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.

Experimental arm

Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies） DRUG

Immune checkpoint inhibitors (ICIs) have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells.

Experimental arm

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Biotherapeutic Department, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Decitabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Weidong Han, Prfessor

  Biotherapeutic Department, Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weidong Han, Professor

CONTACT

+86-10-55499341; hanwdrsw@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: March 30, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

CN (1)