Status:
RECRUITING
A Study of TIL in Advanced Solid Tumors (DFGD)
Lead Sponsor:
Shanghai Juncell Therapeutics
Collaborating Sponsors:
Eastern Hepatobiliary Surgery Hospital
Conditions:
Advanced Solid Tumor
Tumor Infiltrating Lymphocytes
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06488950
Start Date
April 1 2023
End Date
June 30 2027
Last Update
December 16 2025
Active Locations (1)
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1
Third Affiliated Hospital of Naval Medical University
Shanghai, China