Actively Recruiting
A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
Led by Shanghai JMT-Bio Inc. · Updated on 2024-12-10
186
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating JMT601 in a Phase 1, open-label, multi-center study for adults with relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma who have received at least two prior therapies. The study aims to assess the safety of JMT601 and establish the recommended dose for future studies, addressing an important need for this type of lymphoma treatment. Participants receive JMT601 as an intravenous infusion once a week. The study has two parts: a dose-escalation phase with up to six increasing dose levels to find the maximum tolerated dose and a dose-expansion phase using the recommended dose to further evaluate the treatment in two patient groups with different lymphoma types. The first four weeks include close monitoring for dose-limiting toxicities. During the study, participants undergo safety assessments including monitoring for dose-limiting toxicities and treatment-emergent adverse events up to 90 days after the last dose. Researchers will also evaluate effectiveness measures such as overall response rate, duration of response, progression-free survival, and overall survival for up to 12 months. Laboratory tests and drug concentration measurements are collected to understand drug behavior. The study continues until December 2025, with careful follow-up throughout.
CONDITIONS
Brief Title
A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology or cell biology
- Previously received two or more lines of therapy
- Eastern Cooperative Oncology Group (ECOG) physical state score of 0 to 2
- At least one measurable or evaluable lesion according to Lugano 2014 criteria
- Expected survival of at least 3 months
- Suitable organ and hematopoietic function, including neutrophil count ≥ 1.0×10⁹/L; platelets ≥ 75×10⁹/L if no bone marrow invasion or ≥ 50×10⁹/L if bone marrow invasion exists; hemoglobin ≥ 90 g/L
- Serum creatinine ≤ 1.5 times upper limit of normal or creatinine clearance ≥ 50 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal, ALT and AST ≤ 2.5 times upper limit of normal; for subjects with liver lesions: bilirubin ≤ 3 times ULN, ALT and AST ≤ 5 times ULN
- International standardized ratio and activated partial thromboplastin time ≤ 1.5 times upper limit of normal
You will not qualify if you...
- Confirmed central nervous system lymphoma
- Previous allogeneic hematopoietic stem cell transplantation or other organ transplantation
- Prior treatment with targeted CD47 or signal regulatory protein α (SIRPα) therapy
- History of hemolytic anemia, Evans syndrome, or arteritis
- Previous or current other malignant tumors
- Active autoimmune diseases
- Major surgery within 4 weeks before the first dose or planned major surgery during the study
- HIV infection, active syphilis, positive hepatitis B surface antigen with high HBV-DNA, or positive hepatitis C antibody with high HCV-RNA
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive weekly intravenous infusions of JMT601. The first 4 weeks are focused on observing dose-limiting toxicities.
Weekly visits for infusions
Duration - Up to 12 months
Participants are monitored for treatment-emergent adverse events and overall response up to 12 months after treatment.
Visits as scheduled up to 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China
Actively Recruiting
Research Team
Q
Qingjie Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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