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.
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;
Confirmed central nervous system (CNS) lymphoma.
Subjects who have received allogeneic hematopoietic stem cell transplantation (HSCT) or other organ transplantation
Those who have previously received targeted CD47 or signal regulatory protein α (SIRRP α) therapy.
Previous or current hemolytic anemia, Evans syndrome, arteritis;
Single group
JMT601
Biological/Vaccineintravenous infusion on day 1 once a week
Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD)
Incidence of treatment-emergent adverse events (TEAEs)
Overall response rate (ORR)
Defined as the proportion of participants with complete response or partial response measured by Lugano 2014
Duration of response (DOR)
Defined as the time from complete response or partial response to progression disease or death
Progression free survival (PFS)
Defined as the time from initiation of treatment to progression disease or death
Overall survival (OS)
Defined as the time from initiation of treatment to death of any cause
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