A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors

  • End date
    May 30, 2029
  • participants needed
  • sponsor
    Suzhou BlueHorse Therapeutics Co., Ltd.
Updated on 4 October 2022
lung cancer
neutrophil count
liver metastasis
kidney function test
lung carcinoma


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.


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.

Condition Melanoma, Non Small Cell Lung Cancer, Cervical Carcinoma
Treatment Autologous tumor infiltrating lymphocytes (TILs)
Clinical Study IdentifierNCT05366478
SponsorSuzhou BlueHorse Therapeutics Co., Ltd.
Last Modified on4 October 2022


Yes No Not Sure

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
Clear my responses

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