About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • GC203 TIL(gene-edited TIL) or autologous TILs

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1
Third Affiliated Hospital of Naval Medical University Shanghai China

Sponsors and collaborators

Shanghai Juncell Therapeutics

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Collaborator