Non-Hodgkin Lymphoma Clinical Trials

• Unlimited gender, age ≥ 18 years (including critical value)-Cohort 1/2/3;

• Voluntarily participate in the study and sign the ICF, follow the trial treatment protocol and interview plan-Cohort 1/2/3;

• The subject's disease diagnosis meets all of the following conditions:

• Cohort 1:

⁃ Primary central nervous system lymphoma (PCNSL) confirmed by pathology;

⁃ For relapsed or refractory PCNSL, at least first line treatment must be given to Central Nervous System (CNS) lesions;

⁃ Brain Magnatic resonance Imaging (MRI) or Computerized tomography (CT) shows solid lesions of PD;

• Cohort 2:

⁃ CLL/SLL diagnosed according to IWCLL 2008 standards;

⁃ Refractory or relapsed CLL/SLL that previously received at least first-line systemic treatment. First-line treatment is defined as at least 2 cycles of standard protocol or clinical trial research protocol completed based on current guidelines;

⁃ Accord with at least one indication of CLL / SLL that requiring treatment;

⁃ There is medical record confirming that it is invalid or Progression Disease occurs after response for the latest treatment;

⁃ CT /MRI shows measurable lesions, which is defined as at least one lymph node with a maximum axis of more than 1.5 cm and with 2 measurable vertical dimension;

⁃ It is allowed to include the patients with a stable condition involving the central nervous system;

• Cohort 3:

⁃ Mantle cell lymphoma diagnosed by histopathology: including that t (11; 14) (q13; q32) positive by cytogenetic test and / or cyclin D1 highly expressed by immunohistochemistry;

⁃ Who have been pretreated with \> 1 but failed in ≤ 3 different chemotherapies and / or targeted drugs treatment.

⁃ There is a medical record confirming that it is invalid or Progression Disease occurs after response for the latest treatment;

⁃ CT / MRI shows measurable lesions, which is defined as the longest diameter (of ≥1 lymph node) \> 1.5 cm, and 2 vertical diameters is clearly measurable;

⁃ It is allowed to include the patients with a stable condition involving the central nervous system;

• When screening, the status score of Eastern Cooperative Oncology Group (ECOG) is 0 to 2 points-Cohort 1/2/3;

• Estimated survival time ≥ 4 months-Cohort 1/2/3;

• Subjects have appropriate organ functions, the main organ functions meet the following criteria:

‣ Blood routine: Neutrophil absolute value ≥ 1.0(in cohort1, 0.75 in cohort 2/3)×109 /L, platelet ≥ 75(in cohort1, 50 in cohort 2/3, 30×109/L are acceptable if CLL patients have bone marrow involvement, transfusion-dependent thrombocytopenia is excluded )×109 /L, hemoglobin ≥ 80 g/L(in cohort1). \[No blood transfusion and hematopoietic stimulating factor are used within 21 days (7 days in cohort 2/3) before the first administration-Chort1\];

⁃ Blood biochemistry: Total bilirubin (TBIL) ≤ 2 × ULN (unless diagnosed as Gilbert syndrome), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN; serum creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 50 ml / min (calculated according to Cockcroft Gault formula)-Cohort 1/2/3;

⁃ Coagulation function: International Standardized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN-Cohort 1/2/3;

• Fertile female subjects must agree to use contraceptives with an annual failure rate of \< 1% or maintain abstinence (avoid heterosexual intercourse) during the study and at least 90 days after the last administration of the study drug. Contraceptive methods with an annual failure rate of \<1% includes bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing IUD (intrauterine devices), and copper-containing IUD. Male subjects must be sterilized by vasectomy or barrier contraception, and female partners should use the effective contraceptives as described above. In addition, male subjects are not allowed to donate sperm within 90 days after the last administration-Cohort 1/2/3.