An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours

Suzhou BlueHorse Therapeutics

Status and phase: Enrolling; Early Phase 1

Conditions: Solid Tumor

Treatments: Drug: LM303

Study type: Interventional

Funder types: Industry

Identifiers

NCT06695689

LM303-CO-301

Details and patient eligibility

About

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

LM303

Experimental group

Description:

Treatment with LM303 injection

Treatment:

Drug: LM303