Phase
Condition
Lymphoma, B-cell
Treatment
Recombinant CD20 monoclonal antibody-MMAE conjugte for injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed CD20-positive B-cell non-Hodgkin lymphoma;
Relapse or refractory after receiving at least 2 standard treatmentregimens;(Definition of refractory: Patients who did not reach PR in two cycles orCR in four cycles);
At least 1 measurable tumor lesion, the maximum transverse diameter of theintranodal lesion should be > 1.5 cm and that of the extranodal lesion should be > 1.0 cm; CLL/SLL patients have treatment indications according to iwCLL 2018guidelines;
Previously received anti-tumor treatment (such as radiotherapy, chemotherapy,hormone therapy, biotherapy, immunotherapy) at least 28 days before the firstadministration of this study; chemotherapy and hormono therapy should be at least 14days before the first administration of this study; Chinese medicine anti-tumortreatment should be at least 7 days before the first administration of this study
The toxicity of previous anti-tumor treatment has been restored to ≤ grade 1 asdefined by NCI-CTCAE v5.0 (except for alopecia; see Inclusion Criterion 6 forhemoglobin and renal function);
The laboratory test results must meet the following requirements: (It is not allowedto give any blood components, short acting cell growth factor, albumin, etc., within 7 days before laboratory examination; long acting cell growth factor is not allowedto be given within the first 14 days):
Hematology: Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets (PLT) ≥ 90×109/L, hemoglobin (HGB) ≥ 90 g/L;
Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal, total bilirubin (TBIL) ≤ 1.5 timesthe upper limit of normal, (AST and/or ALT ≤ 5 times the upper limit of normalare allowed in patients with liver involvement);
Renal function: Serum creatinine (Cr) ≤ 2 times the upper limit of normal;
Coagulation function: (patients who have not received anticoagulant treatmentbefore enrollment) International normalized ratio (INR) ≤ 1.5 times the upperlimit of normal and activated partial thromboplastin time (APTT) ≤ 1.5 timesthe upper limit of normal;
Pulmonary function test for patients with previous lung underlying disorders:measured/predicted value of vital capacity (VC) ≥ 60%, or diffusing capacity ofthe lungs for carbon monoxide (DLCO) ≥ 50% of predicted value;
≥ 18 years , gender is not limited;
ECOG performance status 0-1;
Life expectancy of greater than 3 months;
Female and male patients of childbearing age and their spouses are willing to carryout adequate contraception throughout the study period, and female patients ofchildbearing age must have negative serum pregnancy test within 7 days before thefirst administration;
Patients voluntarily agree to participate in the study and to sign the informedconsent form.
Exclusion
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded:
A clear history of drug allergy, and a history of ingredient allergy toheterogeneous proteins, biological agents or test drugs;
Active hepatitis B or C, or human immunodeficiency virus (HIV) antibody positive;
Those who are positive for syphilis antibodies and confirmed to be unresolved;
Tumor-infiltrating diseases of the central nervous system;
Accompanied by peripheral or central nervous system diseases;
Investigator-assessed diabetes uncontrolled by drug therapy;
Uncontrollable or symptomatic pleural/abdominal/pelvic effusion or pericardialeffusion;
Patients with other malignancies within the past 5 years;
With active autoimmune diseases (such as systemic lupus erythematosus, rheumatoidarthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia,etc.);
Accompanied by the following serious cardiovascular diseases or central nervoussystem diseases:
Myocardial infarction in nearly 6 months of screening period;
Unstable angina pectoris in the screening period of nearly 3 months;
Cardiac insufficiency (cardiac function grade ≥ NYHA class II);
Severe arrhythmia (e.g., persistent ventricular tachycardia, ventricularfibrillation);
Prolonged QTc interval (male > 450 ms, female > 470 ms);
Second or third degree heart block;
Drug-poorly controlled hypertension (systolic blood pressure > 160mmHg ordiastolic blood pressure > 100mmHg);
Cerebrovascular accident (CVA) or transient ischemic attack (TIA), etc., within 6 months before the administration.
Other serious diseases, including but not limited to active peptic ulcer, activehemorrhage, venous thromboembolic event (VTE) and severe interstitial lung disease;
Accompanied by other serious diseases and serious active infections (such aspneumonia, active tuberculosis, etc.);
Received hematopoietic growth factor treatment within 1 week prior to firstadministration, including colony stimulating factor, interleukin or bloodtransfusion;
The dosage of steroid hormone (prednisone phase equivalent) used greater than 20mg/day within 1 month prior to first administration for more than 14 consecutive daysor immunosuppressive treatment;
Various vaccines were inoculated within 1 month prior to first administration;
Major surgery (except diagnostic biopsy) within 1 month prior to firstadministration;
Patients who received autologous stem cell transplantation within 2 months prior tofirst administration;
Patients who have received allogeneic stem cell transplantation in the past;
Patients with infusion reaction above grade III after previous monoclonal antibodytreatment;
Participate in clinical trials of other drugs or medical devices within 1 monthprior to first administration;
Patients previously treated with CAR-T;
Investigators assessed as unsuitable to participate in this study for other reasons.
Study Design
Study Description
Connect with a study center
Chinese Academy of Medical Sciences, Cancer Hospital
Beijing, Beijing 100021
ChinaSite Not Available
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong 510000
ChinaSite Not Available
Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan 450000
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
ChinaSite Not Available
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215000
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital (TMUCIH)
Tianjin, Tianjin 300000
ChinaSite Not Available
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