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NCT Number: NCT06725524

A Study 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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ruijin Hospital

Shanghai, China

Location status: Recruiting

Location contact

Weili Zhao

CONTACT

[email protected]

86-13512112076

Weili Zhao

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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;

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

Treatment and study plan

JMT601

Biological

intravenous infusion on day 1 once a week

Primary outcomes

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

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

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: TEAEs: Up to 90 days after last dose

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: Up to 12 months

    Defined as the proportion of participants with complete response or partial response measured by Lugano 2014

  2. Duration of response (DOR)

    Time frame: Up to 12 months

    Defined as the time from complete response or partial response to progression disease or death

  3. Progression free survival (PFS)

    Time frame: Up to 12 months

    Defined as the time from initiation of treatment to progression disease or death

  4. Overall survival (OS)

    Time frame: Up to 12 months

    Defined as the time from initiation of treatment to death of any cause

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

    Time frame: Up to 12 months

    Aera under the curve from 0 to the last measurable concentration

  6. Aera under the curve from 0 to the infinite time(AUC0-∞)

    Time frame: Up to 12 months

    Aera under the curve from 0 to the infinite time

  7. Time to maximum concentration(Tmax)

    Time frame: Up to 12 months

    time to maximum concentration

  8. Terminal phase half-life(T1/2)

    Time frame: Up to 12 months

    terminal phase half-life

  9. Clearance(CL)

    Time frame: Up to 12 months

    clearance

  10. Volume(Vd)

    Time frame: Up to 12 months

    volume

  11. Maximum concentration( Cmax)

    Time frame: Up to 12 months

    maximum concentration

  12. Minimum concentration(Cmin)

    Time frame: Up to 12 months

    minimum concentration

  13. Accumulation ratio(AR)

    Time frame: Up to 12 months

    accumulation ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Qingjie Li

CONTACT

[email protected]

86-15877976037

Sponsors and collaborators

Lead sponsor

Shanghai JMT-Bio Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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