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NCT06488950
A Study of TIL in Advanced Solid Tumors (DFGD)
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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