Actively Recruiting
Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies
Led by GC Cell Corporation · Updated on 2025-04-30
48
Participants Needed
3
Research Sites
125 weeks
Total Duration
On this page
Sponsors
G
GC Cell Corporation
Lead Sponsor
A
Artiva Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have relapsed or refractory CD5-positive NK and T-cell malignancies as defined by WHO 2017 classification
- Have failed at least two prior standard chemotherapy treatments with no remaining treatment options
- Have lesions or nodules meeting size criteria per Lugano classification (nodal lesions 1.5 cm, extranodal lesions 1.0 cm) with clear boundaries
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Meet all other protocol-defined criteria
- Use contraception consistent with local regulations during the study
You will not qualify if you...
- Diagnosis of T-ALL/T-LBL or cutaneous T-cell lymphoma (CTCL)
- Presence of central nervous system (CNS) lymphoma or CNS involvement
- History of another malignancy within the past 3 years
- Use of hematopoietic growth factor therapy within 14 days before screening
- Prior treatment with CAR-T or CAR-NK therapies
- Uncontrolled fungal, bacterial, or viral infections requiring intravenous antimicrobial treatment
- Previous allogeneic organ transplantation
- Diagnosis or treatment of primary immunodeficiency
- Acute graft-versus-host disease (GvHD) Grade 3 or higher, or extensive chronic GvHD within 2 weeks before lymphodepletion
- Known active hepatitis B or C infection
- Presence of Grade 2 or higher toxicity from previous treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Seoul National University Hosptial
Seoul, South Korea, 03080
Actively Recruiting
2
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
3
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
H
HyeSung Jeon
CONTACT
S
Seungryel Han
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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