Actively Recruiting
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
Led by Suzhou BlueHorse Therapeutics Co., Ltd. · Updated on 2022-08-02
15
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer, or other solid tumors confirmed by histology and lacking effective or standard treatment
- Presence of residual tumor lesions larger than 1.5 cm3 suitable for surgical removal or biopsy and measurable after resection for TIL collection and evaluation
- Blood tests showing lymphocyte ratio > 20%, neutrophil count > 1.0 x 10^9/L, white blood cells > 3.0 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 80 g/L
- Liver function tests with ALT and AST less than or equal to 2.5 times the upper normal limit (up to 5 times if liver metastasis), alkaline phosphatase less than or equal to 2.5 times upper normal limit, and total bilirubin less than or equal to 1.5 times the upper normal limit
- Kidney function with urea and creatinine less than or equal to 1.5 times the upper normal limit
- Left ventricular ejection fraction of 50% or higher
- Eastern Cooperative Oncology Group (ECOG) physical condition score of 0 or 1
- Expected survival time of more than 3 months
You will not qualify if you...
- Active or previous autoimmune diseases
- Severe dysfunction of liver, kidney, heart, coagulation, or blood cell formation
- Severe or uncontrolled infections
- Metastasis to the central nervous system or cancerous meningitis
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Need for systemic steroid treatment
- Positive tests for hepatitis B surface antigen or core antibody, hepatitis C virus antibody, HIV antibody, or syphilis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Beichen Hospital
Tianjin, China, 300000
Actively Recruiting
Research Team
X
Xu Wen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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