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

ImmuneOncia Therapeutics

Status and phase: Active, not recruiting; Phase 2

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

Treatments: Drug: IMC-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04414163

IMC-001-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

IMC-001

Experimental group

Description:

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

Treatment:

Drug: IMC-001