Lymphoma, T-Cell
Conditions
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 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
DRUGGCC2005
CAR-NK Cell Therapy
DRUGCyclophosphamide
Lymphodepleting chemotherapy
DRUGFludarabine
Lymphodepleting chemotherapy
Sponsors
GC Cell Corporation
Artiva Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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 and regimen optimization and exploratory expansion part (Phase 1b) uses a 3+3 design with optional backfill enrollment to determine MTD and RP2D.
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher | From the time of enrollment through End of Study (up to 18 months per patient) | 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) |
| 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 | From the time of enrollment through End of Study (up to 18 months per patient) | 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) |
Countries
South Korea
Contacts
CONTACTHyeSung Jeon
CONTACTSeungryel Han
Outcome results
None listed