Acute B lymphoblastic leukemia
Conditions
Interventions
Experimental group1:Dosage of the study drug: week 1-4: 0.1 µg/kg A-319
Experimental group2:Dosage of the study drug: week 1-2: 0.1 µg/kg A-319. Dosage of the study drug: week 3-4: 0.2 µg/kg A-319
Experimental group3:Dosage of the study drug: week 1-2: 0.1 µg/kg A-319. Dosage of the study drug: week 3-4: 0.4 µg/kg A-319
Experimental group4:Dosage of the study drug: week 1-2: 0.1 µg/kg A-319. Dosage of the study drug: week 3-4: 0.6 µg/kg A-319
Experimental group5:Dosage of the study drug: week 1-2: 0.1 µg/kg A-319. Dosage of the study drug: week 3-4: 0.8 µg/kg A-319
Experimental group6:Dosage of the study drug: week 1-2: 0.1 µg/kg A-319. Dosage of the study drug: week 3-4: 1.2 µg/kg A-319
Experimental group7:Dosage of the study drug: week 1-2: 0.1 µg/kg A-319. Dosage of the study drug: week 3-4: 2.4 µg/kg A-319
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Diagnosed with CD19-positive precursor B-cell acute lymphoblastic leukemia; 3. Diagnosed with refractory or relapsed acute lymphoblastic leukemia; 4. Eastern Cooperative Oncology Group (ECOG) physical condition score <= 2 points; 5. The patient has at least 5% bone marrow blasts (morphological determination); 6. Life expectancy of at least 3 months; 7. The patient can sign the informed consent form and can comply with the requirements of the program; if the patient cannot sign the informed consent form, it needs to be signed by his legal guardian or representative.
Exclusion criteria
Exclusion criteria: 1. Central nervous system leukemia (determined by cerebrospinal fluid [CSF] analysis) or acute lymphoblastic leukemia with clinically relevant lesions of the central nervous system; 2. Burkitt's leukemia, acute lymphoblastic leukemia testicular infiltration; 3. Philadelphia chromosome-positive acute lymphoblastic leukemia that meets the criteria for TKIs treatment such as imatinib or dasatinib, and is accessible and effective for TKIs treatment; 4. Past or associated with other malignant tumors (except for cured skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, and prostate intraepithelial tumor); 5. Patients with grade 2-4 acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation or those with chronic graft-versus-host disease requiring immunosuppressive therapy; 6. Receive autologous hematopoietic stem cell transplantation (Auto-HSCT) within 6 weeks before the start of study drug treatment, and receive allogeneic hematopoietic stem cell transplantation (Allo-HSCT) within 3 months; 7. Combined chemotherapy, radiotherapy or systemic treatment of GVHD within 2 weeks before the start of study drug treatment; 8. The investigator judges that the patient is accompanied by diseases, medical conditions or social factors that may affect the research results or compliance. The protocol stipulates that the following conditions cannot participate in this study: (1) Uncontrolled acute infection or confirmed bacteremia; (2) Known human immunodeficiency virus (HIV) infection or acute phase of hepatitis B or C; (3) Patients with severe breathing difficulties, pulmonary insufficiency or continuous oxygen inhalation; (4) New York Heart Association [NYHA] cardiac insufficiency class 3 or 4; (5) Myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, severe arrhythmia, uncontrolled hypertension within 6 months before administration, systolic blood pressure > 180 mmHg and diastolic blood pressure > 100 mmHg. 9. Laboratory inspections are specified as follows: (1) Hemoglobin 3 x ULN), and if accompanied by liver metastasis, are greater than 5 times the upper limit of normal (> 5 x ULN); (3) Total bilirubin greater than 1.5 times the upper limit of normal (> 1.5 x ULN); (4) Creatinine clearance rate 1.6 (unless receiving anticoagulant therapy); the dose of oral anticoagulation therapy is unchanged (minimum 14 days), such as oral warfarin, the patient's INR must be <= 3.0, and No bleeding tendency (ie, no bleeding within 14 days prior to the first dose of study drug), subjects were allowed to use low molecular weight heparin. 10. Previously received anti-CD19 therapy (including CAR-T), or received immunotherapy (such as rituximab) within 4 weeks before A-319 therapy; 11. Associated with adverse events (except alopecia) caused by anti-tumor therapy that have not recovered to grade 1; 12. Women of childbearing age who are pregnant (positive pregnancy test) and breastfeeding, and women of childbearing age who do not agree to use contraception within at least 3 months after signing the informed consent form to the end of the study; wom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence and characteristics of adverse events;Dose limited toxicities;Maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak concentration;Pharmacodynamic indicators; | — |
Countries
China
Contacts
Public ContactMi Jianqing
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed