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NCT06488950

A Study of TIL in Advanced Solid Tumors (DFGD)

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Reclutando Fase 1 temprana

Descripción

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Criterios de Elegibilidad

Inclusion Criteria:

  • have one the tumor resection for TILs production and successfully produced;
  • Age: 18 years to 75years;
  • Histologically diagnosed as solid tumors;
  • Expected life-span more than 3 months;
  • ECOG score 0-1;
  • Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;
  • At least 1 evaluable tumor lesion;

Exclusion Criteria:

  • with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
  • Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
  • Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \< 95%;
  • Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
  • Significant cardiovascular anomalies

Información del Ensayo

NCT06488950
Reclutando
Fase 1 temprana
30 participantes
Abr 2023
Jun 2026

Ubicaciones1

China (1)
Third Affiliated Hospital of Naval Medical University
Shanghai Reclutando