A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

NCT06725524 | Recruiting Phase 1

• 1 other identifier: JMT601-001
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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

B-cell Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD)

  DLTs and MTD: Up to 28 days after the first dose

• Incidence of treatment-emergent adverse events (TEAEs)

  TEAEs: Up to 90 days after last dose

Secondary Outcomes (13)

• Overall response rate (ORR)

  Up to 12 months

• Duration of response (DOR)

  Up to 12 months

• Progression free survival (PFS)

  Up to 12 months

• Overall survival (OS)

  Up to 12 months

• Aera under the curve from 0 to the last measurable concentration(AUClast)

  Up to 12 months

Study Arms (1)

JMT601

EXPERIMENTAL

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.

Biological: JMT601

Interventions

JMT601 BIOLOGICAL

intravenous infusion on day 1 once a week

JMT601

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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; Subjects with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN;
• International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN;

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Weili Zhao

  Ruijin Hospital Clinical, Shanghai Jiao Tong University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingjie Li

CONTACT

86-15877976037; liqingjie@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: December 10, 2024
• Study Start: October 12, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)