Tests LM103 cell therapy in adults with advanced melanoma, lung or cervical cancer
Tests LM103, made from a patient's own immune cells, in adults with advanced cancers.
Plain-language title generated from the registry record
Registry title: A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1
Where in China
- Tianjin Beichen HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou BlueHorse Therapeutics Co., Ltd.
- Trial code
- NCT05366478
- Record updated
- 2 August 2022
- Original description
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.Read full original descriptionShow less
A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors
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.
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 ; Requires systemic steroid therapy; 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; 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; Central nervous system metastasis and/or cancerous meningitis; With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.