A Phase 2 interventional study of IMC-001 in Extranodal NK/T-cell Lymphoma, Nasal Type and Extranodal NK/T-cell Lymphoma, sponsored by ImmuneOncia Therapeutics Inc.. Active, not recruiting at 5 sites in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by ImmuneOncia Therapeutics Inc. · Phase 2, Interventional, and Treatment
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
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.
179 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 32 are open to participants now.
This study's enrollment of 23 is below the median of 34 across 161 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Browse Lymphoma, Extranodal NK-T-Cell studies →ImmuneOncia Therapeutics Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ENKTL diagnosis;
Exclusion Criteria:
Single Dose level (IMC-001 20mg/kg, every 2 weeks)
Drug: IMC-001
Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)
Also known as: Danburstotug
Occurrence of Objective Response Rate(ORR)
Lugano criteria with LYRIC modification
Time frame: through study completion, an average of 1 year
Evaluate safety of IMC-001
Terms, frequency, severity and seriousness of AEs and relationship of AEs to IMC-001
Time frame: through study completion, an average of 1 year
Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate
Complete Response (CR) rate, (Unit of Measure: Percentage of participants) 1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification 2. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification 3. based on response as determined by the investigator per the Lugano criteria
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.
Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)
Disease Control Rate (DCR), (Unit of Measure: Percentage of participants) 1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification 2. based on response as determined by the investigator per the Lugano criteria
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.
Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)
Progression-Free Survival (PFS), (Unit of Measure: Months) 1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification 2. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification 3. based on response as determined by the investigator per the Lugano criteria
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.
Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)
Duration of Response (DOR), (Unit of Measure: Months) 1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification 2. based on response as determined by the investigator per the Lugano criteria
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.
Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)
Time to Progression (TTP), (Unit of Measure: Months) 1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification 2. based on response as determined by the investigator per the Lugano criteria
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.
Evaluate additional efficacy variables of IMC-001 : Overall Response Rate (ORR)
Overall Response Rate (ORR), (Unit of Measure: Percentage of participants) 1. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification 2. based on response as determined by the investigator per the Lugano criteria
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.
Evaluate additional efficacy variables of IMC-001 : Overall Survival (OS)
Overall Survival (OS), (Unit of Measure: Months)
Time frame: through study completion, an average of 1 year
Determine the pharmacokinetic (PK) profile of IMC-001 : Ctrough
The trough level or trough concentration (Ctrough) of IMC-001 measured at specified time points.
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)
Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax
The maximum observed serum concentration (Cmax) of IMC-001 observed during dosing interval.
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)
Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA)
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.
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)
Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug Exposure and Activity
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.
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)
Plan to share: No
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Lymphoma, Extranodal NK-T-Cell→
ImmuneOncia Therapeutics Inc.