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OncoMatch/Clinical Trials/NCT05366478

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

Is NCT05366478 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Autologous tumor infiltrating lymphocytes (TILs) for melanoma.

Phase 1RecruitingSuzhou BlueHorse Therapeutics Co., Ltd.NCT05366478Data as of May 2026

Treatment: Autologous tumor infiltrating lymphocytes (TILs)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.

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Extracted eligibility criteria

Cancer type

Melanoma

Small Cell Lung Cancer

Cervical Cancer

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

lymphocyte ratio > 20%; neutrophil count > 1.0 × 10^9/L; WBC > 3.0 × 10^9/L; platelets > 100 × 10^9/L; hemoglobin > 80 g/L

Kidney function

urea ≤ ULN x 1.5; creatinine ≤ ULN x 1.5

Liver function

ALT and AST ≤ ULN x 2.5 (≤ ULN x 5 if liver metastasis); ALP ≤ ULN x 2.5; TBIL ≤ ULN x 1.5

Cardiac function

LVEF ≥ 50%

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: ALT and AST ≤ ULN x 2.5 (≤ ULN x 5 if liver metastasis); ALP ≤ ULN x 2.5; TBIL ≤ ULN x 1.5; Renal function: urea ≤ ULN x 1.5; creatinine ≤ ULN x 1.5; Cardiac: LVEF ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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