Clinical trial · Interventional
A Clinical Study on LM103 Injection for the Treatment of Advanced Solid Tumors
An Exploratory Clinical Study Evaluating the Safety, Tolerance, Immune Response, and Initial Efficacy of Autologous Tumor Infiltrating Lymphocytes (TILs) LM103 Injection in Patients With Advanced Solid Tumors
NCT05971589CI-TRIAL-00068455unknownEarly Phase 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 study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients. The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and Interleukin-2 therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LM103 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravenous of LM103
- description
- ≥5×10\^9 cells (LM103) will be infused i.v. to patients after non-myeloablative lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection.
- interventionNames
- Biological: LM103
Primary outcomes (1)
- measure
- Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)
- timeFrame
- through study completion, an average of 1 year estimate
- description
- Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.
Secondary outcomes (8)
- measure
- Objective response rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The expected survival time is not less than 6 months. 2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1. 3. Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, head and neck squamous cell cancer, soft tissue sarcoma and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available. 4. The patient has lesions that can be used for surgical resection (\>1.5 cm\^3) or biopsy puncture (no less than 6 lesions) for TILs collection. 5. At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria). 6. Laboratory tests results during the screening period indicate that the subjects have sufficient organ function. Exclusion Criteria: 1. Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery). 2. LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases\>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis\>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment. 3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time). 4. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
References
Publications (1)
- DERIVEDLi F, Xu Y, Wang Y, Mu N, Liu M, Feng W, Xue Y, Wu S, Wang X, Lizee G, Ma C. Multiple autologous tumor-infiltrating lymphocyte (LM103 infusion) therapy combined with immune checkpoint inhibitor induces repeated tumor regression in a patient with aggressive mucosal melanoma: a case report and literature review. Front Oncol. 2026 Apr 23;16:1789442. doi: 10.3389/fonc.2026.1789442. eCollection 2026. PMID 42109657