Hematologic malignancy
Conditions
Interventions
Treatment group:BR108
Sponsors
Tianjin Medical University Cancer Institute&Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary agreement to provide written informed consent; 2. Males and females aged >= 18 years; 3. Patients must have an advanced hematologic malignancy including: (1) Relapsed or refractory lymphoma as defined by World Health Organization(WHO) criteria; (2) Relapsed or refractory AML/MDSas defined by World Health Organization (WHO) criteria; 4. Subjects must have documented CD70-positive; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Expected survival time >= 3 months; 7. Have at least 1 evaluable lesion per Lugano 2014; 8. The function of major organs must meet the following criteria (Lymphomahave not received blood transfusion, EPO, G-CSF or other medical supportive treatment within 7 days before the first dose of study drug): (1) White blood cell count = 1.5 x 10^9/L or >= 0.75 x 10^9/L for patients with bone marrow infiltration, Platelet >= 75 x 10^9 /L or >= 50 x 10^9/L for patients with bone marrow infiltration; Hemoglobin >= 8.0 mmol/L or >= 7.0 mmol/L for patients with bone marrow infiltration; (3) International normalized ratio (INR) or prothrombin time (PT) = 60 mL/min ; (5) Total bilirubin <= 1.5 x ULN or <= 3 x ULN for patients with Gilbert's syndrome or liver metastasis Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 x ULN or <= 5 x ULN for patients with liver metastasis: 9. Women of child bearing potential and non-sterilized male patients who are sexually active with a female partner of child bearing potential must agree to use an effective method of contraception from screening until 6 months after the last dose of study drug. Effective methods of contraception consist of prior sterilization, intrauterine device, intrauterine hormone-releasing system, oral or injectable contraceptives, and sexual abstinence. 10. Patients will be able to communicate well with the investigator, understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia, primary central nervous system malignancies or invasion of the central nervous system (except for those who are asymptomatic or stable and do not require treatment >= 4 weeks before the first dose of study drug); 3. Has not recovered from adverse reactions caused by previous anti-tumor treatments to 470 ms; (4) Patients with interstitial lung disease, severe lung dysfunction, severe pulmonary fibrosis, or pulmonary infection requiring systematic treatment; 12. Subjects who have autoimmune disorders and need to rely on immunosuppressive therapy or receive systemic therapy with a dose of >= 20 mg/day of prednisone or other equivalent hormones within 2 weeks before enrollment; 13. Patients have received other clinical trials within 4 weeks before the first dose of study drug; 14. Subjects who have major surgery or severe trauma within 4 weeks prior to initial dosing or plan to take major surgery during the trial period; 15. Treatment with prior anti-cancer therapy (including chemotherapy, endocrine therapy, targeted therapy, etc.) must have been terminated at last 28 days or 5 half-lives (whichever is shorter) before study enrolment, 2 weeks for endocrine therapy and Chinese medicine treatment with anti-tumor indications o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of BR108; Maximum tolerated dose (MTD) and the Recommended phase 2 dose (RP2D);objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS);Pharmacokinetic evaluatio;Immunogenicity evaluation;safety evaluation;disease control rate (DCR);duration of response (DOR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactHuilai Zhang
Outcome results
None listed