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.
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 treatment option considered as assessed by the Investigator.
According to the Lugano classification, Participants 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.
Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Has T-ALL/T-LBL, CTCL or ALCL.
Participants with CNS lymphoma or any involvement of the CNS.
Participants who had a prior history of another malignancy over the last 3 years.
Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening.
Sequential
GCC2005
DrugCAR-NK Cell Therapy
Cyclophosphamide
DrugLymphodepleting chemotherapy
Fludarabine
DrugLymphodepleting chemotherapy
Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher
To evaluate the safety and tolerability of GCC2005 in patients with relapsed/refractory NK/T cell malignancies. Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
To determine MTD and RP2D: Safety(based on frequency, severity, and persistence of AEs and AEs Grade 3 or higher), efficacy (based on ORR) and pharmacokinetics
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
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GC Cell Corporation
Lead sponsor
Artiva Biotherapeutics, Inc.
Collaborator
