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.
Patients with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
Patients with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.
According to the Lugano classification, patients having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.
Patient has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Has T-ALL/T-LBL or CTCL.
Patient with CNS lymphoma or any involvement of the CNS.
Patient who had a prior history of another malignancy over the last 3 years.
Patients who have used hematopoietic growth factor therapy within 14 days prior to Screening.
GC Cell Corporation
Lead sponsor
Artiva Biotherapeutics, Inc.
Collaborator