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GCC2005

Phase 1

Lymphoma, T-Cell | Small molecule | Oncology |Artiva Biotherapeutics, Inc.|Last Updated: Apr 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06699771Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell MalignanciesPHASE1 RECRUITING 48 — — Mar 7, 2025Aug 1, 2027Apr 30, 20253 South Korea
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Study Endpoints
Primary Endpoints
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)

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a Dose Escalation and Phase 1b Dose ExpansionEXPERIMENTALDose Confirmation of GCC2005 in Relapsed or Refractory NK and T-cell Malignancies
Interventions
NameTypeDescription
GCC2005DRUGCAR-NK Cell Therapy
CyclophosphamideDRUGLymphodepleting chemotherapy
FludarabineDRUGLymphodepleting chemotherapy
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Eligibility Criteria
Age Range19 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

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 consid...

Countries:South Korea
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Competitive Landscape -Cutaneous T-Cell Lymphoma 4 trials
CompanyTickerTrialsLead PhaseDrugs
Soligenix, Inc.SNGX1PHASE3Hypericin
Incyte CorporationINCY2PHASE2Ruxolitinib, Pembrolizumab
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1 — Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06699771primaryCompletionDate: changed
LOWMay 24, 2026NCT06699771studyFirstPostDate: changed