Actively Recruiting
A Study 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
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 2 or more lines of therapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- At least one measurable or evaluable lesion per Lugano 2014 criteria
- Expected survival of at least 3 months
- Suitable organ and blood function including:
- Neutrophil count (ANC) ≥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× upper limit of normal (ULN) or creatinine clearance ≥50 mL/min
- Total bilirubin ≤1.5× ULN, ALT and AST ≤2.5× ULN; if liver lesions, total bilirubin ≤3× ULN, ALT and AST ≤5× ULN
- International standardized ratio and activated partial thromboplastin time ≤1.5× ULN
You will not qualify if you...
- Confirmed central nervous system lymphoma
- Previous allogeneic hematopoietic stem cell or other organ transplantation
- Prior treatment with targeted CD47 or signal regulatory protein alpha (SIRP alpha) therapy
- Previous or current hemolytic anemia, Evans syndrome, or arteritis
- History of other malignant tumors
- Active or previous autoimmune diseases
- Major surgery within 4 weeks before starting treatment or planned during the study
- HIV infection, active syphilis
- Positive hepatitis B surface antigen with HBV-DNA above 1000 copies/ml (500 IU/ml)
- Positive hepatitis C antibody with HCV-RNA above 1000 copies/ml
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China
Actively Recruiting
Research Team
Q
Qingjie Li
CONTACT
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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