Evaluating JMT601 for treating relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: liqingjie@cspc.cn
• Phone: 86-15877976037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.