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Recruiting NCT06699771

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

Phase I Interventional Lymphoma, T-Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GCC2005, Cyclophosphamide, Fludarabine.
Who it may be relevant to
Registry conditions: Lymphoma, T-Cell. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 participants and to determine a safety profile of GCC2005 in participant population. Phase 1b of this study is planned to evaluate safety, PK/PD characteristics, and preliminary efficacy following single administration, reflecting the cumulative exposure level obtained with multiple administration based on the safety and tolerability assessment results confirmed in Phase 1a, and to assess dose and regimen optimization to determine the RP2D for subsequent studies.

Interventions

  • Drug GCC2005
    CAR-NK Cell Therapy
  • Drug Cyclophosphamide
    Lymphodepleting chemotherapy
  • Drug Fludarabine
    Lymphodepleting chemotherapy

Primary outcome measures

  • Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher [Time frame: From the time of enrollment through End of Study (up to 18 months per patient)]
  • To determine MTD and RP2D: Safety(based on frequency, severity, and persistence of AEs and AEs Grade 3 or higher), efficacy (based on ORR) and pharmacokinetics [Time frame: From the time of enrollment through End of Study (up to 18 months per patient)]

Eligibility criteria

Inclusion criteria

  • Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
  • Participants 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, Participants 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.
  • Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
  • Participants 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.
  • Participants who comply with all procedures of this study and voluntarily give written consent

Exclusion criteria

  • Has T-ALL/T-LBL, CTCL or ALCL.
  • Participants with CNS lymphoma or any involvement of the CNS.
  • Participants who had a prior history of another malignancy over the last 3 years.
  • Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening.
  • Participants 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
  • Participants with previous allogenic organ transplantation
  • Participants with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.
  • Participants with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.
  • Participants with known active Hepatitis B or C
  • Participants with presence of Grade 2 or greater toxicity from the previous treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 3 centers
  • Seoul National University Hosptial — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT06699771 · GCC2005A-P101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗