RecruitingPhase 1NCT06699771

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


Sponsor

GC Cell Corporation

Enrollment

48 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 study testing a new cell therapy called GCC2005 — designed to target a protein called CD5 on cancer cells — for people with relapsed or treatment-resistant NK-cell or T-cell blood cancers that have not responded to two or more prior lines of chemotherapy. **You may be eligible if...** - You have been diagnosed with a CD5-positive NK-cell or T-cell blood cancer - Your cancer has relapsed or stopped responding after at least two prior standard chemotherapy regimens - There are no other available treatment options in your doctor's assessment - You have at least one measurable tumor - You have a good performance status (ECOG 0–2) **You may NOT be eligible if...** - Your cancer does not express the CD5 protein - You have significant organ dysfunction - You have active infections or autoimmune conditions - You have fewer than two prior lines of chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGCC2005

CAR-NK Cell Therapy

DRUGCyclophosphamide

Lymphodepleting chemotherapy

DRUGFludarabine

Lymphodepleting chemotherapy


Locations(3)

Seoul National University Hosptial

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06699771


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