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

Primary Purpose

Relapsed/Refractory Non-Hodgkin Lymphoma, Advanced Solid Tumors

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Chidamide

Decitabine

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

About this trial

This is an interventional treatment trial for Relapsed/Refractory Non-Hodgkin Lymphoma focused on measuring Relapsed/Refractory Non-Hodgkin Lymphoma, Advanced Solid Tumors, Chidamide, Decitabine, Immune Checkpoint Inhibitors, Chemotherapy free regimen

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Biotherapeutic Department, Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

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).

Progression-free survival (PFS)

Time from the date of first administration of the study drug to disease progression or death from any cause.

Full Information

NCT ID

NCT05320640

First Posted

April 2, 2022

Last Updated

April 8, 2022

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05320640

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2022 (Actual)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Chidamide

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Decitabine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

Time Frame

3 years

Title

Adverse events

Description

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

Secondary Outcome Measure Information:

Title

Duration of response (DOR)

Description

Time Frame

3 years

Title

Progression-free survival (PFS)

Description

Time from the date of first administration of the study drug to disease progression or death from any cause.

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

Biomarkers predictive of response

Description

Biomarkers from tumor cells, lymphocytes and tumor microenvironment will be assessed for their potential in predicting clinical response.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weidong Han, Professor

Phone

+86-10-55499341

hanwdrsw@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weidong Han, Prfessor

Organizational Affiliation

Biotherapeutic Department, Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Biotherapeutic Department, Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Han wei dong, Ph.D

Phone

+86-10-55499341

hanwdrsw@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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