Autologous Tumor-Infiltrating Lymphocyte Mono-Therapy Can Rapidly Shrank Tumor in Asian Patient with Stage III/IV Cervical Cancer: Two Cases Report.
Fenge Li, Yupeng Wang, Jin Yan...
https://pubmed.ncbi.nlm.nih.gov/38222312Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05366478
A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors
Led by Suzhou BlueHorse Therapeutics Co., Ltd. · Updated on 2022-08-02
15
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, antitumor activity, and immune response of LM103 Injection in patients with advanced solid tumors, including melanoma, non-small cell lung cancer, and cervical cancer. This open-label, single-arm exploratory study aims to assess how well this treatment works and how safe it is for patients whose existing treatments are ineffective or unavailable. The treatment involves harvesting tumor-infiltrating lymphocytes (TILs) from the patients tumor sample, expanding them ex vivo, and then transferring them back to the patient intravenously after chemotherapy with cyclophosphamide and fludarabine. LM103 Injection is given as a single dose on day 1, combined with interleukin-2 (IL-2) therapy to support immune response. The study plans to enroll between 9 and 15 patients. Participants will undergo laboratory tests, imaging, and physical assessments to monitor response and safety for up to two years. Researchers will track adverse events for one year and evaluate tumor response, disease control, progression-free survival, and changes in immune activity. The total study duration includes treatment, follow-up, and monitoring to better understand the effects of LM103 Injection in advanced solid tumors.
CONDITIONS
Brief Title
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer, or other solid tumors confirmed by histology
- Existing treatments are ineffective or no standard treatment available
- Residual tumor lesions >1.5 cm3 suitable for surgical resection or biopsy and measurable after resection
- Blood counts within specified limits: lymphocyte ratio >20%, neutrophils >1.0 x 10^9/L, white blood cells >3.0 x 10^9/L, platelets >100 x 10^9/L, hemoglobin >80 g/L
- Liver function within limits: ALT and AST ≤ 2.5x upper normal limit (or ≤ 5x if liver metastasis), ALP ≤ 2.5x upper normal limit, total bilirubin ≤ 1.5x upper normal limit
- Renal function within limits: urea ≤ 1.5x upper normal limit, creatinine ≤ 1.5x upper normal limit
- Left ventricular ejection fraction ≥ 50%
- ECOG performance status 0 or 1
- Expected survival time more than 3 months
You will not qualify if you...
- Active or previous autoimmune diseases
- Severe liver or kidney dysfunction, severe heart disease, coagulation or blood formation disorders
- Severe or persistent infections not effectively controlled
- Central nervous system metastasis or cancerous meningitis
- Uncontrolled pleural, pericardial effusions, or ascites requiring repeated drainage
- Need for systemic steroid therapy
- Positive tests for hepatitis B surface antigen or core antibody, hepatitis C antibody, HIV antibody, or syphilis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Not specified
Participants receive chemotherapy with cyclophosphamide and fludarabine to prepare for treatment.
Not specified
Treatment
Duration - Not specified
Participants are treated with a single dose of LM103 Injection combined with IL-2 following infusion of expanded autologous tumor infiltrating lymphocytes (TILs).
1 treatment visit (in-person)
Follow-up
Duration - Up to 2 years
Participants are monitored for safety, efficacy, and immunoreactivity changes for up to 2 years after treatment.
Regular follow-up visits (exact number not specified)
Trial Site Locations
Total: 1 location
1
Tianjin Beichen Hospital
Tianjin, China, 300000
Actively Recruiting
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Research Team
X
Xu Wen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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