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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04924413
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Quanli Gao
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Quanli Gao, Ph.D
Principal Investigator Affiliation	Henan Cancer Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Melanoma

Arms & Interventions

Arms

Experimental: L-TIL and Tislelizumab

L-TIL（3-10）x10*9/m2, Q3W, 4 cycles Tislelizumab 200mg, iv, Q3W, 1 year

Interventions

Drug: - Tislelizumab

PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Quanli Gao, Ph.D

zlyygql0855@zzu.edu.cn

0371-65587483

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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