A Study of TIL in Advanced Solid Tumors (DFGD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GC203 TIL(gene-edited TIL) or autologous TILs.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor, Tumor Infiltrating Lymphocytes, Treatment Side Effects, Effects of Immunotherapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101/203 TIL) in Patients With Advanced Solid Tumors
Overview
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.
Interventions
- Biological GC203 TIL(gene-edited TIL) or autologous TILs
the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample
Primary outcome measures
- Adverse Events [Time frame: 6 months]
Secondary outcome measures (4)
- Objective Response Rate (ORR) [Time frame: Up to 36 months]
- Disease Control Rate (DCR） [Time frame: Up to 36 months]
- Duration of Response (DOR) [Time frame: Up to 36 months]
- Progression-Free Survival (PFS) [Time frame: Up to 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Third Affiliated Hospital of Naval Medical University — Shanghai
Identifiers
NCT: NCT06488950 · GC101/203-2023-DFGD-ST