Clinical trial NCT06699771: Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lymphoma, T-Cell
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
Collaborators: name: Artiva Biotherapeutics, Inc.
First posted: 2024-11-21
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher
timeFrame: From the time of enrollment through End of Study (up to 18 months per patient)
measure: 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
timeFrame: From the time of enrollment through End of Study (up to 18 months per patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hosptial
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: