A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor

Exclusion Criteria

• •1. B-cell lymphoma: known central nervous system (CNS) involvement .
• •2. Advanced solid tumors: Patients with active brain metastases (defined as stable for \< 4 weeks, or symptomatic, or requiring antiepileptic drug/hormonal therapy, or meningeal metastases);
• •3. Subjects with prior allogeneic HSCT who have developed acute graft-versus-host disease (GVHD) or persistent evidence of chronic GVHD (as manifested by ≥ Grade 2 serum bilirubin, ≥ Grade 3 skin involvement, or ≥ Grade 3 diarrhea or receiving systemic immunosuppressive therapy/prophylaxis for GVHD);
• •4. Subjects have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease recurrence and adequately treated carcinoma in situ without evidence of disease recurrence,et al;
• •5. History of severe bleeding disorders ;
• •6. History of chronic pancreatitis or acute pancreatitis within 6 months;
• •7. History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease;
• •8. Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage after intubation and drainage, VEGF inhibitors, platinum and other drugs injection (subjects with stable symptoms for at least one week after treatment can be enrolled);
• •9. Prior solid organ transplantation;
• •10. Persistent peripheral neuropathy \> Grade 1 at baseline;
• •11. Clinically significant cardiovascular or cerebrovascular diseases;
• •12. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic therapy (except for localized skin or nail bed fungal infection) at enrollment;
• •13. Active infectious disease, such as HIV infection, active hepatitis B, active hepatitis C (positive RNA result), active syphilis;
• •14. Receiving corticosteroids (prednisone equivalent more than 30 mg/day);
• •15. Contraindication to any component of HDM2005;
• •16. History of drug anaphylactic shock, severe food allergy, uncontrolled asthma/COPD;
• •17. Female subjects who are pregnant, lactating or planning to become pregnant during the study;
• •18. Known history of mental illness or substance abuse that would impair the subject's ability to cooperate with study requirements;
• •19. Prior or current evidence of any disease, treatment, or laboratory abnormality that, in the opinion of the investigator, could affect the outcome of the study, prevent the subject from participating in the study entirely, or is not in the subjects' best interest.