A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Incidence and severity of adverse events (AEs)
Study Overview
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 tolerability, antitumor activity and immunoreactivity.
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 chemotherapy with cyclophosphamide and fludarabine. LM103 will be administered as a single dose on day 1. TIL transfer will be combined with IL-2 treatment. This study is planned to enroll 9-15 patients with advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
Autologous tumor infiltrating lymphocytes (TILs)
In vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors
Intervention: Autologous tumor infiltrating lymphocytes (TILs) (Drug)
Outcomes
Primary Outcomes
Incidence and severity of adverse events (AEs)
Time Frame: Up to 1 years
Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Secondary Outcomes
- Number of Participants With Objective Response(Up to 2 years)
- Disease Control Rate (DCR）(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)
- The changes of the immunoreactivity during treatment(Up to 2 years)