NCT06699771

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: GC Cell Corporation · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	GCC2005	CAR-NK Cell Therapy
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy
DRUG	Fludarabine	Lymphodepleting chemotherapy

Timeline

• Start date: 2025-03-07
• Primary completion: 2026-04-01
• Completion: 2027-08-01
• First posted: 2024-11-21
• Last updated: 2025-04-30

Locations

3 sites across 1 country: South Korea