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RECRUITING
NCT03658785
PHASE1/PHASE2

Immunotherapy for the Treatment of Advanced Solid Tumor

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, side effects and benefits of autologous tumor infiltrating lymphocytes (TIL) specific to personalized Neo-antigens in the treatment of patients with recurrent, metastatic and advanced solid tumors.

Official title: Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Solid Tumor

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-04-28

Completion Date

2025-12-31

Last Updated

2024-08-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

TIL

On day 0, cells will be infused intravenously over 20 to 30 minutes (one to four days after the last dose of fludarabine)

DRUG

Aldesleukin

IL-2 125,000 IU/kg/day IV (based on total body weight) beginning within 24 hours of cell infusion and continuing for up to 2 weeks

DRUG

Cyclophosphamide

On day -7 and day -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

DRUG

Fludarabine

Days -5 to -1: Fludarabine 25 mg /m2/day IVPB daily over 30 minutes for 5 days

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China