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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

NCT04872634 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-07-21

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

SNK01 (Super Natural Killer Cells 01)

Investigational Product : SNK01 (Super Natural Killer Cells 01) Principal Component : Autologous Natural Killer Cell To induce anti-tumor immunity in Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior TKI therapy for EGFR, ALK, or ROS1 Gene Mutation and to strengthen the Antibody-Dependent Cellular Cytotoxicity (ADCC) of Cetuximab, 4x10\^9 or 6x10\^9 cells are infused through the veins of the subjects within 45 minutes (±15 minutes) per 100 mL total 8 times at intervals of one week.

DRUG

GC

Gemcitabine; 1000mg/m2, Day 1, Day 8, 4-cycle administration, Mixed with normal saline 50ml and administered into a vein for 30 min. Carboplatin; AUC 5, Day 1, 4-cycle administration, Mixed with 5% Dextrose 200ml and administered into a vein for 1 hour.

BIOLOGICAL

Cetuximab

First administration: 400mg/m2 Subsequent administration: 250mg/m2 (Premedication before administration\*) Weekly Administration continues until the disease progresses or unacceptable toxicity develops. 400mg/m2: Administered into a vein for 120 minutes 250mg/m2: Administered into a vein for 60 minutes

Sponsors & Collaborators

  • NKMAX Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2023-05-26
Completion
2023-05-26

Countries

  • South Korea

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872634 on ClinicalTrials.gov