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SNK02

Phase 1

Pathologically Confirmed Cancer Refractory to Conventional Therapy | Biologics | Oncology |NKGen Biotech, Inc.|Trials Updated: Nov 20, 2024

SNK02 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

SNK02 clinical trials

SNK02 · 1 trial · 8 indications

Phase 1 1
NCT05990920Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional TherapyPathologically Confirmed Cancer Refractory to Conventional Therapy
COMPLETED6 Analytics
PHASE1COMPLETED
Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy
Pathologically Confirmed Cancer Refractory to Conventional Therapy
NCT059909206
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Study Endpoints

Primary Endpoints

Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs
4 weeks

Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs

MTD and/or RP2D
8 weeks

Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
12 weeks

Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALSNK02 will be administered as an IV infusion weekly for 8 weeks.

Interventions

NameTypeDescription
SNK02BIOLOGICALSNK02 is ex vivo expanded allogeneic NK cells for IV injection, is a light-yellow cryopreserved cell suspension consisting of NK cells isolated from healthy donor's peripheral blood mononuclear cells.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Pathologically confirmed diagnosis of refractory cancer that has failed at least prior line of conventional standard of care therapy. * Diagnosed with any histologically confirmed malignancy whose disease is confirmed to be metastatic and/or unresectable for which standard cur...

Countries:United States
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