Actively Recruiting
An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours
Led by Suzhou BlueHorse Therapeutics Co., Ltd. · Updated on 2024-11-19
10
Participants Needed
1
Research Sites
154 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 LM303 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
An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer, or other solid tumors confirmed by histology where existing treatments are ineffective or unavailable
- Residual tumor lesions larger than 1.5 cm3 suitable for surgical removal or biopsy for TIL collection and efficacy assessment
- Blood tests showing lymphocyte ratio above 20%, neutrophil count above 1.0 x 10^9/L, white blood cells above 3.0 x 10^9/L, platelets above 100 x 10^9/L, and hemoglobin above 80 g/L
- Liver function with ALT and AST less than 2.5 times the upper normal limit (up to 5 times if liver metastasis present), ALP less than 2.5 times upper normal limit, and total bilirubin less than 1.5 times the upper normal limit
- Kidney function with urea and creatinine less than 1.5 times the upper normal limit
- Left ventricular ejection fraction of 50% or higher
- ECOG physical status of 0 or 1
- Expected survival time longer than 3 months
You will not qualify if you...
- Having active or previous autoimmune diseases
- Severe dysfunction of liver, kidney, heart, blood clotting, or blood formation
- Severe or persistent infections that cannot be controlled effectively
- Metastasis to the central nervous system or cancerous meningitis
- Uncontrolled pleural, pericardial, or abdominal fluid requiring repeated drainage
- Need for systemic steroid therapy
- Positive 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
F
Feng e Li
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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