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

I

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)

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

Trial contacts and locations

5

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Central trial contact

MinYoung Son; JiEun Oh

Data sourced from clinicaltrials.gov

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