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

NCT ID: NCT06699771

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2027-08-31

Brief Summary

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.

Detailed Description

The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of GCC2005 in treatment of patients with relapsed or refractory NK cell and T-cell malignancies expressing CD5. Phase 1a of the study will be conducted to establish a dose range that is well tolerated by the majority of patients and to provide a safety profile of GCC2005 in target patient population. Phase 1b of the study is planned to conduct dose optimization to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

Conditions

Lymphoma, T-Cell

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a Dose Escalation and Phase 1b Dose Expansion

Dose Confirmation of GCC2005 in Relapsed or Refractory NK and T-cell Malignancies

Group Type: EXPERIMENTAL

GCC2005

Intervention Type: DRUG

CAR-NK Cell Therapy

Cyclophosphamide

Intervention Type: DRUG

Lymphodepleting chemotherapy

Fludarabine

Intervention Type: DRUG

Lymphodepleting chemotherapy

Interventions

GCC2005

CAR-NK Cell Therapy

Intervention Type: DRUG

Cyclophosphamide

Lymphodepleting chemotherapy

Intervention Type: DRUG

Fludarabine

Lymphodepleting chemotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• Patients who satisfy the criteria defined in the protocol.
• Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

• 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.
• Patients who have had prior CAR-T or CAR-NK therapies.
• Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management
• Patients with previous allogenic organ transplantation
• Patients with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.
• Patients with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.
• Patients with known active Hepatitis B or C
• Patients with presence of Grade 2 or greater toxicity from the previous treatment.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Artiva Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

GC Cell Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hosptial

Seoul, , South Korea

Site Status: RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

HyeSung Jeon

Role: CONTACT

hs_jeon@gccorp.com

+82-31-260-9059

Seungryel Han

Role: CONTACT

hansr@gccorp.com

+82-31-260-9771

Facility Contacts

Youngil Koh, MD

Role: primary

go01@snu.ac.kr

+82-2-2072-7217

DokHyun Yoon, MD

Role: primary

dhyoon@amc.seoul.kr

+82-2-3010-5940

Won Seog Kim, MD

Role: primary

wonseog.kim@samsung.com

+82-2-2148-7390

Other Identifiers

GCC2005A-P101

Identifier Type: -

Identifier Source: org_study_id