Treatment of advanced solid tumors with LM103 Injection

A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors

This study is testing a new injection called LM103 to see if it can help people with advanced solid tumors like melanoma and lung cancer feel better after chemotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, cyclophosphamide, fludarabine
• Locations: 1 site (Tianjin)
• Trial ID: NCT05366478 on ClinicalTrials.gov

What this trial studies

This exploratory study evaluates the safety and efficacy of LM103 Injection in patients with advanced solid tumors, including melanoma, non-small cell lung cancer, and cervical carcinoma. It involves a single-arm, open-label design where expanded tumor infiltrating lymphocytes (TILs) are transferred to patients following chemotherapy. The LM103 Injection is administered as a single dose, and the study aims to assess antitumor activity and immunoreactivity. A total of 9-15 patients will be enrolled to determine the treatment's tolerability and effectiveness.

Who should consider this trial

Good fit: Ideal candidates include patients with stage III or IV melanoma, non-small cell lung cancer, cervical carcinoma, or other solid tumors who have ineffective treatment options.

Not a fit: Patients with early-stage tumors or those who have effective standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to existing treatments.

How similar studies have performed: Other studies utilizing tumor infiltrating lymphocytes have shown promise in treating advanced cancers, indicating potential for success in this approach.

Eligibility criteria

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;

Where this trial is running

Tianjin

• Tianjin Beichen Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Fenge Le, Ph.D — Tianjin Beichen Hospital
• Study coordinator: Xu Wen

Conditions Melanoma; Non Small Cell Lung Cancer; Cervical Carcinoma