Non Hodgkin Lymphoma
Conditions
Brief summary
This is a Phase I/II clinical trial for patients with r/r Non-Hodgkin's Lymphoma relapsed after chimeric antigen receptor T cells infusion. The purpose is to evaluate the safety and efficacy of the treatment with chidamide in combination with decitabine.
Interventions
DRUGChidamide
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; Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.
DRUGDecitabine
Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.
DRUGCamrelizumab
Camrelizumab is a humanized anti-PD-1 monoclonal antibody.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion. 2. 18 to 65 years of age. 3. ECOG performance of less than 2. 4. Life expectancy of at least 3 months. 5. Subjects with lymphoma must have at least one measureable new lesion \>1.5cm as defined by lymphoma response criteria. 6. Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1. 7. Subjects must have adequate marrow, live, renal and heart functions.
Exclusion criteria
1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month . 4. Prior organ allograft. 5. Women who are pregnant or breastfeeding. 6. Women with a positive pregnancy test on enrollment or prior to investigational product administration. 7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR rate | 2 years | CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects |
| Adverse events | 2 years | Adverse events were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0) |
Countries
China
Outcome results
None listed