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

NCT ID: NCT06725524

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

JMT601

Intervention Type: BIOLOGICAL

intravenous infusion on day 1 once a week

Interventions

JMT601

intravenous infusion on day 1 once a week

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai JMT-Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weili Zhao

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Ruijin Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingjie Li

Role: CONTACT

Phone: 86-15877976037

Email: liqingjie@cspc.cn

Facility Contacts

Weili Zhao

Role: primary

Other Identifiers

JMT601-001

Identifier Type: -

Identifier Source: org_study_id