UnknownPhase 1/2

A Study to Evaluate the Safety and Anti-tumor Activity of SNK01 (NK Cells) Administered in Combination With Chemotherapy or Chemotherapy / Cetuximab in Local Advanced or Metastatic Non-small Cell Lung Cancer Patients Who Failed Tyrosine Kinase Inhibitor Treatment

South Korea24 participantsStarted 2021-07-08

Plain-language summary

This clinical trial is a Single-Center, Open, Phase I/IIa Clinical Trial conducted to evaluate the safety and anti-tumor activity of SNK01 and GC +/- Cetuximab administered in combination to Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior Tyrosine Kinase Inhibitor (TKI) therapy at least once. After the start of the clinical trial, the first 3 subjects complete the enrollment in Cohort 1 in serial order and then 3 subjects are enrolled in Cohort 2 in serial order. After this, Cohorts 1, 3 and Cohorts 2, 4 are independently processed and subjects are enrolled in serial order when new cohorts start and/or replacement subjects are required. For the subjects who are additionally enrolled after the DLT evaluation and the MTD is determined in each dose cohort, no DLT evaluation is conducted. The subjects allotted to each cohort are administered with the SNK01 manufactured from peripheral blood mononuclear cells total 8 times over a period of about 10 weeks. Combined administration of SNK01 starts from the Cycle 2 (Week 4) of Cytotoxic Chemotherapy and SNK01 is administered at an interval of 1 week starting from the day after the administration of Cytotoxic Chemotherapy and/or Cetuximab (Visit 5-1, D23). When no disease progression is confirmed at EOT (End of Treatment), disease progression is checked until the clinical trial is over. The adverse events which have occurred during the study period are monitored until the date when the investigator judges that no monitoring is required as the symptom has disappeared or there is no further change in the symptom or the 30th day (±3 d) from the latest date of the administration among Gemcitabine, Carboplatin and Cetuximab after the EOT, whichever comes first. For all the subjects enrolled in the present clinical trial, safety is checked in accordance with CTCAE V5.0 and effectiveness is checked in accordance with RECIST V1.1 through the vital signs, laboratory test, adverse events, etc. during the study period.

Who can participate

Age range20 Years

SexALL

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Exclusion criteria

✕. Those who have undergone systemic Cytotoxic Chemotherapy, administration of a biologic agent, or a surgery within 3 weeks prior to the enrollment date
✕. Those who have undergone Breast Radiotherapy of which the radiation exceeds 30 gray (Gy) for treatment of Non-small Cell Lung Cancer within 6 months prior to the enrollment date
✕. Those who have undergone Palliative Radiotherapy on the regions to which a lung cancer is metastasized (bone, brain, etc.) within 1 week before the enrollment date
✕. Those who have undergone therapy of EGFR TKIs (Gefitinib, Erlotinib, Afatinib, Osimertinib, etc.), ALK TKIs (Crizotinib, Ceretinib, Alectinib, Brigatinib, etc.) and/or ROS1 TKIs (Crizotinib, etc.) within 2 weeks of the enrollment date
✕. if a lesion exists on the region other than the area of CNS metastasis that can be evaluated or measured by RECIST V1.1;
✕. if it is radiologically confirmed before the enrollment that the lesion is stabilized after the area of CNS metastasis has been treated;
✕. if the patients have no anamnesis of intracranial hemorrhage or myelorrhagia; and
✕. if the patients have clinically stable symptomless lesion for minimum 2 weeks after treatment of the CNS metastasis and stopping use of anticonvulsant or steroid.

What they're measuring

Maximum Tolerated Dose of the dose of SNK01 + GC + (or Cetuximab)

Timeframe: 28 days

Adverse event

Timeframe: Up to 12 months

Trial details

NCT IDNCT04872634

SponsorNKMAX Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-26

View on ClinicalTrials.gov More Non-small Cell Lung Cancer trials