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NCT Number: NCT04414163

A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type Extranodal NK/T-cell Lymphoma Lymphoma Lymphoma, Extranodal NK-T-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonnam National University Hwasun Hospital, Gwangju, South Korea

Loading trial locations.

About this study

IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ENKTL diagnosis;
  • Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasal type
  • At least 1 previous line of systemic therapy
  • Documented disease progression of last therapy
  • Adult age(as defined by respective country)
  • The nature of the study and voluntarily sign an ICF
  • ECOG 0 or1
  • Adequate hematologic function, hepatic function, and renal function

Exclusion criteria

  • Previously treated with an anti-PD-L1 or anti-PD-1 antibody
  • Known presence of symptomatic CNS metastases
  • Prior allogeneic HSCT or solid organ transplantation
  • Any active autoimmune disease or a documented history of autoimmune disease
  • Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus
  • Pregnant or lactating

Treatment and study plan

IMC-001

Drug

Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)

Other names: Danburstotug

Primary outcomes

  1. Occurrence of Objective Response Rate(ORR)

    Time frame: through study completion, an average of 1 year

    Lugano criteria with LYRIC modification

Secondary outcomes

  1. Evaluate safety of IMC-001

    Time frame: through study completion, an average of 1 year

    Terms, frequency, severity and seriousness of AEs and relationship of AEs to IMC-001

  2. Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate

    Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

    Complete Response (CR) rate, (Unit of Measure: Percentage of participants)

    • Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
    • Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
    • based on response as determined by the investigator per the Lugano criteria

  3. Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)

    Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

    Disease Control Rate (DCR), (Unit of Measure: Percentage of participants)

    • Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
    • based on response as determined by the investigator per the Lugano criteria

  4. Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)

    Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

    Progression-Free Survival (PFS), (Unit of Measure: Months)

    • Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
    • Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
    • based on response as determined by the investigator per the Lugano criteria

  5. Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)

    Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

    Duration of Response (DOR), (Unit of Measure: Months)

    • Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
    • based on response as determined by the investigator per the Lugano criteria

  6. Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)

    Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

    Time to Progression (TTP), (Unit of Measure: Months)

    • Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
    • based on response as determined by the investigator per the Lugano criteria

  7. Evaluate additional efficacy variables of IMC-001 : Overall Response Rate (ORR)

    Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

    Overall Response Rate (ORR), (Unit of Measure: Percentage of participants)

    • Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
    • based on response as determined by the investigator per the Lugano criteria

  8. Evaluate additional efficacy variables of IMC-001 : Overall Survival (OS)

    Time frame: through study completion, an average of 1 year

    Overall Survival (OS), (Unit of Measure: Months)

  9. Determine the pharmacokinetic (PK) profile of IMC-001 : Ctrough

    Time frame: Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)

    The trough level or trough concentration (Ctrough) of IMC-001 measured at specified time points.

  10. Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax

    Time frame: Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)

    The maximum observed serum concentration (Cmax) of IMC-001 observed during dosing interval.

  11. Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA)

    Time frame: Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)

    Incidence of anti-drug antibody (ADA) (including serum titers of anti-IMC-001 antibodies) The percentage of patients demonstrating anti-IMC-001 antibodies will be calculated.

  12. Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug Exposure and Activity

    Time frame: Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)

    Correlation Between ADA and Drug Exposure and Activity The Spearman nonparametric correlation coefficient will be calculated to quantify the relationship between titer of anti-IMC-001 antibodies and exposure and activity.

Sponsors and collaborators

Lead sponsor

ImmuneOncia Therapeutics Inc.

Industry

Registry information

Official study title

An Open-label, Single-arm, Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Jun 4, 2020
Registry last updated
Apr 24, 2026

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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