Clinical trial · Interventional
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors
NCT05366478CI-TRIAL-00060026recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous tumor infiltrating lymphocytes (TILs) | Drug | Lifileucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous tumor infiltrating lymphocytes (TILs)
- description
- In vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors
- interventionNames
- Drug: Autologous tumor infiltrating lymphocytes (TILs)
Primary outcomes (1)
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
- Up to 1 years
- description
- Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Secondary outcomes (4)
- measure
- Number of Participants With Objective Response
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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; 2. 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; 3. 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; 4. Left ventricular ejection fraction (LVEF) ≥ 50%; 5. ECOG physical condition is 0 or 1; 6. The expected survival time is more than 3 months; Exclusion Criteria: 1. Suffering from active or previous autoimmune diseases ; 2. Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction; 3. Combined with severe infection or persistent infection and cannot be effectively controlled; 4. Central nervous system metastasis and/or cancerous meningitis; 5. With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 6. Requires systemic steroid therapy; 7. 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;
References
Publications (2)
- DERIVEDLi F, Yang J, Lizee G, Xue Y, Wang R, Zhang C, Gao X, Zhao X, Liu M, Lu W, Wang Y, Feng W, Ma C, Ma Y. T cell receptor repertoire dynamics and newly identified functional regulators of autologous tumor-infiltrating lymphocyte therapy in advanced solid tumors. J Transl Med. 2026 Aug 11;24(1):1068. doi: 10.1186/s12967-026-08781-z. PMID 42618927
- DERIVEDLi F, Wang Y, Yan J, Wu H, Du X, Feng W, Zhang X, Xue Y, Wang H, Liu W. Autologous Tumor-Infiltrating Lymphocyte Mono-Therapy Can Rapidly Shrank Tumor in Asian Patient with Stage III/IV Cervical Cancer: Two Cases Report. Int J Womens Health. 2024 Jan 9;16:31-39. doi: 10.2147/IJWH.S446768. eCollection 2024. PMID 38222312