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NCT06695689

Un estudio clínico iniciado por el investigador sobre la inyección de LM303 para el tratamiento de tumores sólidos avanzados.

Reclutando Fase 1 temprana

Descripción

Este es un estudio exploratorio, de un solo brazo, abierto y no aleatorizado, para evaluar la seguridad y la eficacia de la inyección de LM303 en pacientes con tumores sólidos avanzados. El objetivo de este estudio es evaluar la seguridad y la tolerabilidad, la actividad antitumoral y la inmunorreactividad.

Criterios de Elegibilidad

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;

Información del Ensayo

NCT06695689
Reclutando
Fase 1 temprana
10 participantes
Oct 2024

Ubicaciones1

China (1)
Tianjin Beichen Hospital
Tianjin, 300000 Reclutando