L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. This study plan to include stage III or IV unresectable or metastatic cutaneous or acral malignant melanoma patients, treat with L-TIL 4 cycles with each infusion (3 -10) x10*9/m2 cells, combined with tislelizumab 200mg, iv, Q3W. It is expected that 30 patients will be enrolled in this study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Quanli Gao

Criteria

Inclusion Criteria:

1. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination

3. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection.

8. Other tumor disease.

Exclusion Criteria:

1. Symptomatic brain metastases

2. Active infection

3. Active HBV or HCV infection

4. HIV infection

5. Autoimmune disease

6. Sensitive to drug or ingredients

7. Severe mental disorders

8. Sever disfunction of heart, liver and kidney