Active — Not RecruitingPhase 2

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

South Korea23 participantsStarted 2020-10-27

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. ENKTL diagnosis;
✓. Adult age(as defined by respective country)
✓. The nature of the study and voluntarily sign an ICF
✓. ECOG 0 or1
✓. Adequate hematologic function, hepatic function, and renal function

Exclusion criteria

✕. Previously treated with an anti-PD-L1 or anti-PD-1 antibody
✕. Known presence of symptomatic CNS metastases
✕. Prior allogeneic HSCT or solid organ transplantation
✕. Any active autoimmune disease or a documented history of autoimmune disease
✕. Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus
✕. Pregnant or lactating

What they're measuring

Occurrence of Objective Response Rate(ORR)

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT04414163

SponsorImmuneOncia Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-23

View on ClinicalTrials.gov More Extranodal NK/T-cell Lymphoma, Nasal Type trials