Evaluating JMT601 for treating 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

This study is testing a new treatment called JMT601 to see if it can help people with relapsed or hard-to-treat CD20-positive B-cell non-Hodgkin lymphoma feel better and stay safe during the process.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai JMT-Bio Inc. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06725524 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, multi-center study aims to assess the safety and determine the recommended dose of JMT601 for patients with relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma. The study consists of two parts: a dose-escalation phase using a 3+3 design with multiple dose cohorts and a dose-expansion phase to evaluate preliminary efficacy at the recommended Phase 2 dose. Participants will be closely monitored for safety and response to treatment throughout the study.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with CD20-positive B-cell non-Hodgkin lymphoma who have received two or more prior therapies.

Not a fit: Patients with early-stage or CD20-negative B-cell non-Hodgkin lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell non-Hodgkin lymphoma.

How similar studies have performed: Other studies have shown promise with similar approaches in targeting CD20-positive B-cell malignancies, suggesting potential for success.

Eligibility criteria

Key Inclusion 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:

  1. The absolute count of neutrophil (ANC) ≥1.0×109/L;
  2. Platelets ≥75×10\^9/L (if bone marrow invasion doesn't exist)/≥50.0×10\^9/L (if bone marrow invasion exists);
  3. Hemoglobin ≥90 g/L;
  4. Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min;
  5. Total bilirubin ≤1.5×ULN, alanine aminotransferase ≤2.5×ULN, aspartate aminotransferase ≤2.5×ULN; Subjects with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN;
  6. International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN;

Key Exclusion Criteria:

* 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;
* Subjects with previous or current other malignant tumors;
* Previous or current history of active autoimmune diseases;
* Subjects 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 copies /ml

Where this trial is running

Shanghai

• Ruijin Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Weili Zhao — Ruijin Hospital Clinical, Shanghai Jiao Tong University, School of Medicine
• Study coordinator: Qingjie Li

Conditions B-cell Non Hodgkin Lymphoma