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

NCT06699771 | Recruiting Phase 1

• 1 other identifier: GCC2005A-P101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphoma, T-Cell

Outcome Measures

Primary Outcomes (2)

• Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher

  To evaluate the safety and tolerability of GCC2005 in patients with relapsed/refractory NK/T cell malignancies. Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)

  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

  To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)

  From the time of enrollment through End of Study (up to 18 months per patient)

Study Arms (1)

Phase 1a Dose Escalation and Phase 1b Dose Expansion

EXPERIMENTAL

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

Drug: GCC2005; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

GCC2005 DRUG

CAR-NK Cell Therapy

Phase 1a Dose Escalation and Phase 1b Dose Expansion

Cyclophosphamide DRUG

Lymphodepleting chemotherapy

Phase 1a Dose Escalation and Phase 1b Dose Expansion

Fludarabine DRUG

Lymphodepleting chemotherapy

Phase 1a Dose Escalation and Phase 1b Dose Expansion

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GC Cell Corporation: lead
• Artiva Biotherapeutics, Inc.: collaborator

Study Sites (3)

Seoul National University Hosptial

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

HyeSung Jeon

CONTACT

+82-31-260-9059; hs_jeon@gccorp.com

Seungryel Han

CONTACT

+82-31-260-9771; hansr@gccorp.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The dose-escalation part of the study (Phase 1a) employs a 3+3 design to determine the DLT of GCC2005. The dose-expansion part of the study (Phase 1b) will enroll patients in two cohorts to determine MTD and RP2D.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: March 7, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)