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

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.

Study Overview

• Status: Recruiting
• Conditions: B-cell Non Hodgkin Lymphoma
• Intervention / Treatment: Biological: JMT601

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qingjie Li; Phone Number: 86-15877976037; Email: liqingjie@cspc.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital
    • Principal Investigator: Weili Zhao
    • Contact: Weili Zhao; Phone Number: 86-13512112076; Email: zwl_trial@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: JMT601; 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; intravenous infusion on day 1 once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Defined as the proportion of participants with complete response or partial response measured by Lugano 2014	Up to 12 months
Duration of response (DOR)	Defined as the time from complete response or partial response to progression disease or death	Up to 12 months
Progression free survival (PFS)	Defined as the time from initiation of treatment to progression disease or death	Up to 12 months
Overall survival (OS)	Defined as the time from initiation of treatment to death of any cause	Up to 12 months
Aera under the curve from 0 to the last measurable concentration(AUClast)	Aera under the curve from 0 to the last measurable concentration	Up to 12 months
Aera under the curve from 0 to the infinite time(AUC0-∞)	Aera under the curve from 0 to the infinite time	Up to 12 months
Time to maximum concentration(Tmax)	time to maximum concentration	Up to 12 months
Terminal phase half-life(T1/2)	terminal phase half-life	Up to 12 months
Clearance(CL)	clearance	Up to 12 months
Volume(Vd)	volume	Up to 12 months
Maximum concentration( Cmax)	maximum concentration	Up to 12 months
Minimum concentration(Cmin)	minimum concentration	Up to 12 months
Accumulation ratio(AR)	accumulation ratio	Up to 12 months

Collaborators and Investigators

• Sponsor: Shanghai JMT-Bio Inc.
• Investigators: Principal Investigator: Weili Zhao, Ruijin Hospital Clinical, Shanghai Jiao Tong University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: JMT601-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No