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

Phase 1

Recruiting

• Conditions: B-cell Non Hodgkin Lymphoma
• Interventions: Biological: JMT601

• Registration Number: NCT06725524
• Lead Sponsor: Shanghai JMT-Bio Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2023-07-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JMT601	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China