RecruitingPhase 1NCT06725524

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

A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

Sponsor

Shanghai JMT-Bio Inc.

Enrollment

186 participants

Start Date

Oct 12, 2021

Study Type

INTERVENTIONAL

Conditions

B-cell Non Hodgkin Lymphoma

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests JMT601, a new type of targeted antibody therapy (bispecific antibody), in patients with relapsed or treatment-resistant B-cell non-Hodgkin lymphoma whose cancer did not respond to at least two prior treatments. **You may be eligible if...** - Have B-cell non-Hodgkin lymphoma confirmed by tissue testing, and it is CD20-positive (a marker on cancer cells) - Have received at least 2 prior treatment regimens and they did not work or stopped working - Have at least one measurable area of cancer on scans - Are able to perform daily self-care activities (ECOG 0–2) **You may NOT be eligible if...** - Cancer is no longer CD20-positive - Have active CNS lymphoma (cancer in the brain/spinal cord) - Have had recent bone marrow or organ transplant - Have active serious infections or autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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