A Study of GC203 TIL in Advanced Solid Tumors (NF)
ConditionSolid Tumors, Adult
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Juncell Therapeutics
About this trial
This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.
Eligibility criteria
Qualifiers
have one the tumor resection for gene-edited GC203 TIL production and successfully produced；
Age: 18 years to 75years;
Histologically diagnosed as solid tumor;
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
8 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Shanghai Juncell Therapeutics
Lead sponsor
Shenzhen Hospital of Southern Medical University
Collaborator
Source ClinicalTrials.gov