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

Phase 2

Active, not recruiting

• Conditions: Extranodal NK/T-cell Lymphoma; Extranodal NK/T-cell Lymphoma, Nasal Type
• Interventions: Drug: IMC-001

• Registration Number: NCT04414163
• Lead Sponsor: ImmuneOncia Therapeutics Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-04
• Study Start: 2020-07-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-07-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMC-001	IMC-001	Single Dose level (IMC-001 20mg/kg, every 2 weeks)

Primary Outcome Measures

Name	Time	Method
Occurrence of Objective Response Rate(ORR)	1 year (Not confirmed yet)	Lugano criteria with LYRIC modification

Trial Locations

Locations (5)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chonnam National University Hwasun Hospital; 🇰🇷 Gwangju, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of