lymphomas and advanced malignant solid tumors
Conditions
Interventions
experimental group:MIL95
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients, >=18 years of age; 2. Diagnosis of Refractory/relapsed lymphomas or solid tumor; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4. Life expectancy >=3 months; 5. Sufficient organ and bone marrow function; 6. At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014); 7. Able and willing to provide written informed consent and to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Prior use of any anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start; 2. Previous exposure to any drug targeting CD47 or SIRPa; 3. Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment; 4. Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period; 5. Central nervous system metastasis; 6. History of other primary malignant tumors in 5 years; 7. Evidence of significant, uncontrolled concomitant disease; 8. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA ); 9. Active or suspected autoimmune diseases; 10. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments; 11. Known history of hemolytic anemia; 12. Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preliminary evaluation of duration of response (DOR) of MIL95 in patients with relapsed or refractory lymphoma and advanced malignant solid tumors;To evaluate the pharmacodynamics of MIL95 in patients with relapsed or refractory lymphoma and advanced malignant solid tumors (RBC and lymphocyte CD47 receptor occupancy;Laboratory test values of hemoglobin and reticulocyte;Absolute value of lymphocyte subsets); | — |
Countries
China
Contacts
Public ContactYuqin Song
Beijing Cancer Hospital
Outcome results
None listed