Advanced Solid Tumor, Effects of Immunotherapy, Treatment Side Effects, Tumor Infiltrating Lymphocytes
Conditions
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 resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Interventions
BIOLOGICALGC203 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
Sponsors
Eastern Hepatobiliary Surgery Hospital
Shanghai Juncell Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 6 months | To characterize the safety profile of TILs in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 36 months | Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) |
| Disease Control Rate (DCR） | Up to 36 months | Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1 |
| Duration of Response (DOR) | Up to 36 months | The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1 |
| Progression-Free Survival (PFS) | Up to 36 months | The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1 |
Countries
China
Contacts
Primary ContactGC Clinical
Outcome results
None listed