Project

A Phase Ib Study on Autologous GC101 TIL Injection for the Treatment of NSCLC (MIZAR-005)

Introduction

GC203 is engineered with self-associating membrane-bound interleukin-7, which can maintain the stemness of memory T cells, activate internal immune cells and avoid systemic toxicities.

The study (MIZAR-005)is an open-label, single-arm phase 1b clinical trial, aimed to investigate the safety and efficacy of GC203 in the Non-small-cell lung cancer (NSCLC) patients.

Main inclusion criteria for subjects

1.  Aged ≥18 years and ≤70 years, regardless of gender;

2. Patients with unresectable advanced, recurrent, or metastatic non-small cell lung cancer who are positive for driver genes and have failed after targeted and platinum-containing dual chemotherapy;

3. 2 lesions at least; able to undergo the surgery to collect tumor tissue;

4. With a ECOG score of 0-1;

5. With sufficient hematology and end-organ function.

Main exclusion criteria for subjects

1.  Suffering from severe organic or psychiatric illness;

2. Suffering from infectious diseases, such as tuberculosis, HIV, syphilis, hepatitis A, hepatitis B, hepatitis C, etc;

3. Pulmonary fibrosis, interstitial lung disease (both past history and current), and acute lung disease; 

4. Patients with clinically symptomatic central nervous system metastases (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases). 

Note: Only the main inclusion and exclusion criteria are listed above, the eligibility of individual subjects is to be judged by the physician after thorough evaluation according to the clinical trial.