Status:
RECRUITING
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
Lead Sponsor:
Suzhou BlueHorse Therapeutics Co., Ltd.
Conditions:
Melanoma
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 t...
Detailed Description
This is an investigator initiated , single-arm, open-label ,exploratory study of LM103 Injection in patients with advanced solid tumors. Expanded TILs will be transferred to the patient after chemothe...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2029
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05366478
Start Date
May 30 2022
End Date
May 30 2029
Last Update
August 2 2022
Active Locations (1)
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1
Tianjin Beichen Hospital
Tianjin, China, 300000