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

Extranodal NK/T-cell Lymphoma Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04414163
• Other study ID #: IMC-001-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 28, 2020
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: ImmuneOncia Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: February 28, 2026
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma
• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Gwangju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
ImmuneOncia Therapeutics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Objective Response Rate(ORR)	Lugano criteria with LYRIC modification	1 year (Not confirmed yet)