Using tumor infiltrating lymphocytes to treat advanced solid tumors
A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101/203 TIL) in Patients With Advanced Solid Tumors
This study is testing a new treatment using specially modified immune cells from tumors to see if it can help people with advanced solid tumors feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Juncell Therapeutics Industry-sponsored |
| Drugs / interventions | Prednisone, cyclophosphamide |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06488950 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. The approach involves expanding autologous TILs and gene-edited TILs from tumor resections or biopsies, which are then infused into the patient after a non-myeloablative lymphodepletion treatment. The treatment regimen includes hydroxychloroquine and cyclophosphamide to prepare the patient's immune system for the TIL infusion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors, specifically those who have failed standard treatments or have no available options.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors who have exhausted standard treatment options.
How similar studies have performed: Other studies using TIL therapy have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Third Affiliated Hospital of Naval Medical University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Qian Zhang — Eastern Hepatobiliary Surgery Hospital
- Study coordinator: GC Clinical
- Email: clinicaltrials@juncell.com
- Phone: 086-18001759113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.