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

Phase 2Active Not RecruitingNCT04414163

ImmuneOncia Therapeutics Inc.23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type Extranodal NK/T-cell Lymphoma

Interventions

IMC-001DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Adult age(as defined by respective country) 3. The nature of the study and voluntarily sign an ICF 4. ECOG 0 or1 5. Adequate hematologic function, hepatic function, and renal function Exclusion Criteria: 1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody 2. Known presence of symptomatic CNS metastases 3. Prior allogeneic HSCT or solid organ transplantation 4. Any active autoimmune disease or a documented history of autoimmune disease 5. Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus 6. Pregnant or lactating

Locations (5)

Chonnam National University Hwasun Hospital

Gwangju, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Occurrence of Objective Response Rate(ORR)

Lugano criteria with LYRIC modification

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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