Actively Recruiting
A Phase 1, Multicenter Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of GCC2005 With Lymphodepleting Chemotherapy in Treatment of Patients With Relapsed or Refractory NK and T-cell Malignancies
Led by GC Cell Corporation · Updated on 2025-04-30
48
Participants Needed
3
Research Sites
69 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
Researchers are evaluating GCC2005, a CAR-NK cell therapy, for treating patients with relapsed or refractory natural killer (NK) and T-cell malignancies that express CD5. This Phase 1, first-in-human, single-arm, open-label trial aims to assess the safety, tolerability, and preliminary efficacy of GCC2005 in patients who have received at least two prior lines of therapy. The study includes two parts: Phase 1a to establish a safe dose range and Phase 1b to optimize dosing by determining the maximum tolerated dose and recommended Phase 2 dose. Participants will receive GCC2005 combined with lymphodepleting chemotherapy using cyclophosphamide and fludarabine. Phase 1a involves dose escalation to find a tolerable dose, followed by Phase 1b dose expansion to confirm safety and efficacy at the selected dose. The treatment plan includes lymphodepleting chemotherapy prior to infusion of GCC2005. The study is conducted across multiple centers and monitors patients for up to 18 months. During the trial, participants will be closely monitored for adverse events and treatment effects. Researchers will evaluate safety by tracking the frequency, severity, and duration of side effects, particularly those graded 3 or higher. They will also assess preliminary efficacy by measuring overall response rate and pharmacokinetics. The study involves regular clinical evaluations, laboratory tests, and ongoing safety assessments throughout the follow-up period.
CONDITIONS
Brief 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...
- Patients with relapsed or refractory CD5-positive NK and T-cell malignancies as classified by WHO 2017
- Patients previously treated with two or more lines of standard chemotherapy and with no further treatment options
- Patients with measurable lesions/nodules as defined by Lugano classification (nodal lesions 21 1.5 cm, extranodal lesions 21 1.0 cm)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients who meet all protocol-defined criteria
- Men and women using contraception consistent with local clinical study regulations
You will not qualify if you...
- Diagnosis of T-ALL, T-LBL, or CTCL
- Presence of central nervous system lymphoma or CNS involvement
- History of another malignancy within the last 3 years
- Use of hematopoietic growth factor therapy within 14 days before screening
- Prior treatment with CAR-T or CAR-NK therapies
- Uncontrolled infections requiring intravenous antimicrobials
- Previous allogeneic organ transplantation
- Diagnosed primary immunodeficiency or current therapy for it
- Acute GvHD grade 3 or higher, or extensive chronic GvHD within 2 weeks of 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - A few days prior to treatment
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine before GCC2005 treatment.
1 to 2 visits (in-person)
Duration - Up to 18 months per participant or until discontinuation
Participants receive GCC2005 CAR-NK cell therapy to assess safety, tolerability, and preliminary efficacy.
Multiple visits for treatment administration and monitoring
Duration - Up to 18 months per participant
Participants are monitored for adverse events, safety, and treatment efficacy after GCC2005 administration.
Regular visits throughout follow-up period
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
S
Seungryel Han
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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