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

NCT ID: NCT04414163

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2026-02-28

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMC-001

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

Group Type: EXPERIMENTAL

IMC-001

Intervention Type: DRUG

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

Interventions

IMC-001

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

Intervention Type: DRUG

Other Intervention Names

Not confirm yet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneOncia Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Won Seog Kim

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Republic of Korea

Locations

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

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

IMC-001-201

Identifier Type: -

Identifier Source: org_study_id