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New treatment option for B-cell Non Hodgkin Lymphoma
Official title A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT06725524
What this study is testing
What is JMT601?
JMT601 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for b-cell non hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participants diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology and/or cell biology who have previously received 2...
- 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;
- Suitable organ and hematopoietic function:
You likely can't join if
- Confirmed central nervous system (CNS) lymphoma.
- people 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;
- people with previous or current other malignant tumors;
- Previous or current history of active autoimmune diseases;
See the full eligibility criteria
- 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;
- Suitable organ and hematopoietic function:
- The absolute count of neutrophil (ANC) ≥1.0×109/L;
- Platelets ≥75×10\^9/L (if bone marrow invasion doesn't exist)/≥50.0×10\^9/L (if bone marrow invasion exists);
- Hemoglobin ≥90 g/L;
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min;
- Total bilirubin ≤1.5×ULN, alanine aminotransferase ≤2.5×ULN, aspartate aminotransferase ≤2.5×ULN; people with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN;
- International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN; Key
- Confirmed central nervous system (CNS) lymphoma.
- people 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;
- people with previous or current other malignant tumors;
- Previous or current history of active autoimmune diseases;
- people who had undergone major surgery within 4 weeks prior to initial dosing or expected to have major surgery during the study period;
- HIV infection, active syphilis, hepatitis B surface antigen (HBsAg) positive and HBV-DNA higher than the lower limit or 1000 copies /ml(500 IU/ml), HCV antibody positive and HCV-RNA higher than the lower limit or 1000...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.