A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai JMT-Bio Inc.

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • JMT601

Treatment groups

186 Participants
are divided into 1 treatment group

Sponsors and collaborators