A Study of GC203 TIL in PDCA (RJ)

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Juncell Therapeutics

About this trial

This study is to investigate the safety and efficacy of gene-edited tumor infiltrating lymphocyte (GC203 TIL) therapy in patients with pancreatic ductal adenocarcinoma. 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 done the tumor resection for gene-edited GC203 TIL production and successfully produced;

Age: 18 years to 70 years;

Histologically diagnosed as pancreatic ductal adenocarcinoma;

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

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators