Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies

This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed/refractory (R/R) NK or T-cell malignancies who have received at least two prior lines of therapy.

Trial Details

NCT ID
NCT06699771
Phase
PHASE1
Sponsor
GC Cell Corporation
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • GCC2005
  • Cyclophosphamide
  • Fludarabine
Locations (sample)
  • Seoul, Seoul, South Korea|37.566,126.9784
  • Seoul, Seoul, South Korea|37.566,126.9784
  • Seoul, Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
  • Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any tr…
  • According to the Lugano classification, Participants having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1…
  • Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.

For full eligibility, visit ClinicalTrials.gov.

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