A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
Trial Parameters
Brief Summary
This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.
Eligibility Criteria
Key Inclusion Criteria: * Participants diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology and/or cell biology who have previously received 2 or more lines of therapy * Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2 * Participants must have at least one evaluable or measurable lesion according to Lugano 2014 criteria. * Expected survival of at least 3 months; * Suitable organ and hematopoietic function: 1. The absolute count of neutrophil (ANC) ≥1.0×109/L; 2. Platelets ≥75×10\^9/L (if bone marrow invasion doesn't exist)/≥50.0×10\^9/L (if bone marrow invasion exists); 3. Hemoglobin ≥90 g/L; 4. Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min; 5. Total bilirubin ≤1.5×ULN, alanine aminotransferase ≤2.5×ULN, aspartate aminotransferase ≤2.5×ULN; Subjects with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN; 6. International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN; Key Exclusion Criteria: * Confi