RecruitingPhase 1NCT05366478

A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors

A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors

Sponsor

Suzhou BlueHorse Therapeutics Co., Ltd.

Enrollment

15 participants

Start Date

May 30, 2022

Study Type

INTERVENTIONAL

Conditions

Melanoma

Summary

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM103 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;
The patient has residual lesions that can be used for surgical resection (\>1.5cm3) or biopsy (\>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;
Laboratory inspection index requirements:
Blood routine: lymphocyte ratio \> 20%; neutrophil count \> 1.0 × 10\^9/L; white blood cells \> 3.0 × 10\^9/L; platelets \> 100 × 10\^9/L; hemoglobin \> 80 g/ L;
Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (ALP) ≤ upper limit of normal x 2.5; total gallbladder Red pigment (TBIL)≤normal upper limit×1.5;
Renal function: urea ≤ upper limit of normal × 1.5; creatinine (Cr) ≤ upper limit of normal × 1.5;
Left ventricular ejection fraction (LVEF) ≥ 50%;
ECOG physical condition is 0 or 1;
The expected survival time is more than 3 months;

Exclusion Criteria7

Suffering from active or previous autoimmune diseases ;
Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
Combined with severe infection or persistent infection and cannot be effectively controlled;
Central nervous system metastasis and/or cancerous meningitis;
With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
Requires systemic steroid therapy;
Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb); positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis;

Interventions

DRUGAutologous tumor infiltrating lymphocytes (TILs)

A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients will be infused with LM103 Injection followed by IL-2.