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

Launched by SUZHOU BLUEHORSE THERAPEUTICS CO., LTD. · May 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LM103 Injection for patients with advanced solid tumors, specifically melanoma, non-small cell lung cancer, and cervical cancer. The goal of the study is to see how safe the injection is and whether it can effectively help shrink the tumors. The trial is currently looking for participants aged 65-74 who have stage III or IV cancer that isn’t responding to current treatments or doesn’t have standard options available.

To be eligible, patients need to have measurable tumors that can be surgically removed or biopsied. They should also be in relatively good health, with certain blood and organ function levels. However, individuals with severe health issues, active infections, or specific viral infections like hepatitis or HIV cannot participate. If you join the trial, you will receive the LM103 Injection and be monitored closely by the medical team to assess how well it works and if there are any side effects. This trial represents a hopeful option for patients seeking new treatments for tough-to-treat cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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;
• • 2. 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;
• 3. 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;
• • 4. Left ventricular ejection fraction (LVEF) ≥ 50%;
• • 5. ECOG physical condition is 0 or 1;
• • 6. The expected survival time is more than 3 months;
• Exclusion Criteria:
• • 1. Suffering from active or previous autoimmune diseases ;
• • 2. Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
• • 3. Combined with severe infection or persistent infection and cannot be effectively controlled;
• • 4. Central nervous system metastasis and/or cancerous meningitis;
• • 5. With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• • 6. Requires systemic steroid therapy;
• • 7. 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;