Clinical trial · Interventional
A Study of JMT601 in Participants With 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Non Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMT601 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JMT601
- description
- Subjects will receive JMT601 once a week. The first 4-week period is for DLT observation. Dose escalation part will be carried out according to 3+3 dose-escalation 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. Dose expansion part will continue at the determined RP2D. Dose expansion part consists of two cohorts: Cohort A: Subjects with CD20-positive diffuse large B-cell lymphoma, prior at least two lines of therapy. Cohort B: Subjects with CD20-positive follicular lymphoma, prior at least two lines of therapy.
- interventionNames
- Biological: JMT601
Primary outcomes (2)
- measure
- Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD)
- timeFrame
- DLTs and MTD: Up to 28 days after the first dose
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- TEAEs: Up to 90 days after last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available