Non-Hodgkin Lymphoma
Conditions
Interventions
Case series:SHR1210, SHR6390
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years at the time of signing the informed consent 2. Histologically confirmed relapsed/refractory mature T-cell lymphoma NK cell or B-cell NHL. The relapsed NHL is Defined as patient suffering the occurrence of new lesions at the primary site or other sites after complete or partial response after adequate treatment.Patients must have received at least one prior therapy (no radiotherapy)for B-cell NHL; The refractory(NHL) is defined as patient received standard treatment and had progressive disease after 2 cycles, evaluation, or patient didn,t achieve partial response (PR)after 4 cycles or complete response (CR) after 6 cycles. The eligible previous treatment for T-NHL is CHOP, EPOCH or similar regimens, for NKTL is L-ASP based regimens ,and cetuximab or cetuximab analogue based regimens for CD20 positive B-NHL; 3. The basis for evaluation should be had at least one two-dimensional measurable lesion: intra-junction lesions, defined as: long diameter = 1.5 cm and short diameter = 1.0 cm; extranodal lesions, long diameter should be = 1.0 cm; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, Estimated Survival Period=3 months; 5. Organ and bone marrow functionas defined below: (1) Absolute neutrophil count (ANC)= 1,500/mm 3 (1.5 ×10^9/L); (2) Platelets = 80,000/mm 3 (100 ×10^9/L); (3) Hemoglobin = 9 g/dL(90 g/L); (4) Serum creatinine= 1.5 X upper limit of normal (ULN)? or creatinine clearance = 60 ml/min (Application of Standard Cockcroft-Gault Formula); (5) total bilirubin =1.5 X upper limit of normal (ULN); (6) Aspartate aminotransferases (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = 2.5 X ULN OR = 5 X ULN for subjects with liver metastases g) Thyroid stimulating hormone (TSH) is within normal range: If TSH is abnormal, free triterpene thyroxine (FT3) and free thyroxine (FT4) need to be within normal limits; 6. Subjects have used chemotherapy drugs or other research drugs before the first dose need to stop taking drugs for more than 3 weeks, have undergone surgery need more than 3 weeks of treatment, receive molecular targeted therapy, palliative radiotherapy, and have used CFDA in the past. Approved Chinese medicine with anti-cancer indications Chinese medicine practitioners with anti-tumor indications need to be treated for more than 2 weeks, and all adverse events (except for hair loss) that occur during treatment have stabilized and returned to the standard level of admission or toxicity= l; 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy; 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Has allergic diseases, a history of severe drug allergies, hypersensitivity to SHR6390 or SHR1210 or any of their excipients 2. Has malignant tumors besides squamous cell carcinoma of skin, basal cell carcinoma of skin and carcinoma in situ of cervix over the past five years; 3. Has absorptive syndrome or other conditions that may impair the absorption of the study drug; 4. Has known active central nervous system (CNS) lymphoma (Have symptoms or need hormone therapy); 5. Has active autoimmune disease or a history of autoimmune disease(Including but not limited to: rheumatoid arthritis, autoimmune pulmonary interstitial fibrosis, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, autoimmune thyroid disease; suffering from vitiligo or allergic in childhood Asthma has been completely relieved and can be included without any intervention after adulthood; allergic asthma requiring bronchodilators and/or medical intervention cannot be included; 6. Due to certain conditions subjects are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. (Prednisone > 10 mg/day or equivalent dose of other similar drugs). Attention: In the absence of active autoimmune disease, adrenal drug replacement with prednisone or equivalent drug dose = 10 mg/day is permitted; subjects are allowed to use topical, ocular, intra-articular, intranasal, and inhalation Type glucocorticoid therapy (very low systemic absorption); short-term (= 7 days) use of glucocorticoids for prophylactic treatment (eg contrast allergy) or for the treatment of non-autoimmune diseases (eg, Delayed hypersensitivity reaction induced by contact allergen). 7. With serious infections(Including but not limited to progressive or active infections).(Need intravenous infusion of antibiotics, antifungal or antiviral drugs, etc); 8. With serious medical disease.Such as grade II and above of cardiac dysfunction (NYHA standard), ischemic heart disease (such as myocardial infarction or angina) and other cardiovascular diseases, poorly controlled diabetes, poorly controlled hypertension; 9. Has a tendency to bleed or is receiving thrombolytic or anticoagulant therapy; 10. Chronic hepatitis B (HBcAg positive) or hepatitis B core antibody (HbcAb) positive and HBV DNA titer exceeds the upper limit of normal detection; or chronic hepatitis C blood positive (HCV antibody positive) positive and HCV DNA titer exceeds normal detection The upper limit of the value; 11. Has a positive medical history of human immunodeficiency virus (HIV) or has acquired immunodeficiency syndrome (AIDS); 12. Has additional malignancy that requires active systemic treatment during the study; 13. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent, car-T cell therapy or other drug therapies for immunomodulatory receptor preparations; 14. Has a history of Interstitial lung disease, chemical pneumonia, allergic pneumonia, connective tissue disease pneumonia, pulmonary fibrosis, acute lung disease, etc(Except for local interstitial pneumonia induced by radiotherapy); 15. Has undergone prior autologous hematopoietic stem cell transplantation, solid organ transplantation, allogeneic hematopoietic stem cell transplantation within 3 months; 16. Has received immunotherapy with irAE grade=3; 17. Has a certain nerve or mental disorders (including dementia) affect the judgment or influence the coll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactQingyuan zhang
Harbin Medical University Cancer Hospital
Outcome results
None listed