Recurrent or refractory primary mediastinal large B-cell lymphoma
Conditions
Interventions
Treatment group:Intravenously give 1200 mg HS636 every 3 weeks until the disease progressed, became intolerable or lost follow-up.
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; fully understand and know the research and sign ICF; willing to follow and have the ability to complete all trial procedures; 2. Aged >=18 years (subject to the day of signing the informed consent), both male and female; 3. The enrolled subjects must have histologically confirmed primary mediastinal large B-cell lymphoma (PMBCL) (WHO Lymphoma Classification, Fourth Edition, revised in 2017), and the previous treatment conditions meet the following conditions; For patients who can accept autologous stem cell transplantation (ASCT), they relapse after ASCT or do not reach complete remission (CR) within 60 days after ASCT. Patients who relapse or refractory after ASCT may have received other interventions, so such patients need to relapse or refractory after the latest treatment; For patients who can not accept ASCT, they have received the treatment of >=2L in the past, and they are ineffective or relapse after the last line of treatment. Local radiotherapy is not considered as a single treatment thread for patients who receive consolidation local radiotherapy after systemic therapy; The previous treatment plan contains rituximab, or cannot accept rituximab for any reason; 4. ECoG score: 0 or 1; 5. There is at least one measurable lesion in two vertical directions (the longest diameter of intranodal lesion > 1.5cm, or extranodal lesion > 1.0cm) (according to Lugano 2014 standard); 6. The expected survival time is at least 3 months; 7. Subjects who have received anti-tumor therapy in the past can be enrolled only after the toxicity of previous treatment has stabilized and returned to the baseline level (except for residual hair loss effect) or CTCAE V5.0 grade score =1.0 x 10^9 / L; platelet count (PLT) >= 75 x 10^9 / L; hemoglobin >= 80 g / L; 2) Liver function: TBIL = 50ml / min; 4) Coagulation function: APTT and INR <= 1.5 x ULN; 9. When female subjects of childbearing age enter the study, the pregnancy test must be negative; female subjects of childbearing age or male subjects and their partners should agree to take effective contraceptive measures from signing ICF to 120 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Participating in other clinical trials or within 4 weeks before enrollment; 2. Patients with known central nervous system involvement (the subjects were in complete remission by imaging and cytological examination, except for clinical complete remission); 3. History of active autoimmune diseases or autoimmune diseases that may recur, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Except those requiring only replacement therapy (such as thyroxine, insulin or corticosteroid replacement therapy for adrenal or pituitary insufficiency); 4. Patients with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 5. Subjects who need to receive systemic glucocorticoid (prednisone > 10 mg / day or equivalent dose of other similar drugs) or other immunosuppressants for certain conditions within 14 days before enrollment; The corticosteroids are used for prevention and treatment (such as contrast agent allergy), for treatment of non autoimmune diseases (such as hypersensitivity caused by contact allergens), except for AE, SAE, etc. after trial medication; 6. Patients who had received monoclonal antibody treatment within 4 weeks before enrollment and had adverse events due to previous treatment (CTCAE V5.0 grade > 1); 7. Received systemic anti-tumor therapy, including chemotherapy and targeted therapy, within 2 weeks before enrollment; received radiotherapy within 4 weeks before enrollment; and had adverse events due to previous treatment (CTCAE V5.0 grade > 1); For those who have received major surgical treatment in the past, the toxicity and / or complications of the subjects must be fully recovered and treated before receiving the research treatment; 8. Allogeneic hematopoietic stem cell transplantation was performed within 5 years before enrollment [except for patients without graft versus host disease (GVHD)]; 9. There is interstitial lung disease or non infectious pneumonia, and there are residual lesions (except local interstitial pneumonia induced by radiotherapy); 10. There was active infection at the time of enrollment and systemic treatment was needed; 11. Human immunodeficiency virus (HIV) antibody positive; hepatitis C virus (HCV) antibody positive and HCV RNA positive; hepatitis B surface antigen (HBsAg) positive and HBV DNA positive; 12. Active tuberculosis or history of tuberculosis; 13. Vaccinated or planned to receive live / attenuated vaccine during the study period within 4 weeks before enrollment; 14. Known to have severe allergic reaction to monoclonal antibody; 15. Known history of alcohol or drug abuse; 16. Patients with major cardiovascular diseases (such as congestive heart failure, unstable angina pectoris, atrial fibrillation, arrhythmia, etc.); 17. Patients with mental history; 18. Patients with any other malignant tumor in the past five years, excluding those with cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin who have been completely cured; 19. Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 or anti-CTLA-4 antibody (or any other antibody acting on T cell costimulation or checkpoint pathway); 20. Other researchers think that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by independent center imaging was defined as the proportion of patients whose best total response (BOR) was complete response (CR) or partial response (PR); | — |
Secondary
| Measure | Time frame |
|---|---|
| The objective response rate (ORR) assessed by the investigator was defined as the proportion of patients whose best total response (BOR) was complete response (CR) or partial response (PR);The duration of remission (DOR) assessed by independent center imaging was defined as the time from the first CR / PR to the first PD or death, whichever occurred first;The disease control rate (DCR) assessed by independent center imaging was defined as the proportion of Cr + PR + SD;Progression free survival (PFS) assessed by independent center imaging was defined as the time from the first administration of hs636 to disease progression or death, whichever occurred first;Overall survival (OS) was defined as the time from the first administration of hs636 to death (death from any cause);Pharmacokinetic evaluation;Safety assessment;Immunogenicity evaluation; | — |
Countries
China
Contacts
Public ContactZhiming Li
Sun Yat-Sen University Cancer Center
Outcome results
None listed