TCR-T Cell Therapy on Advanced Solid Tumors

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Pancreatic Cancer
Interventions
BIOLOGICAL

TCR-T therapy

"1.Preprocessing strategy:~1. Cyclophosphamide: 300-450mg/m², dissolved in 100ml 0.9% sodium chloride saline, intravenous drip for 60minutes, and 0.4g Mesna injected at 0hour, 4hours and 8 hours after cyclophosphamide,4days and 5 days before TCR-T cell infusion.~2. Fludarabine: 30mg/m² , dissolved in 100ml 0.9% sodium chloride saline, intravenous drip for 30minutes before 3 to 5days before TCR-T cell infusion.~2.Within 3-5 days after pretreatment, subjects will receive a single TCR-T reinfusion with an infusion dose of about 1 × 10⁹~1 × 10¹⁰.~3.Once every 12 hours within 24 hours after TCR-T cell infusion, recombinant human interleukin-2 (injection unit: 500000 units /m², once every 12 hours, subcutaneous injection) will be injected intravenously for 5 days (10 times in total).~4.After 3 months of treatment, If the subject did not occur tumor progression and did not occur adverse events (AEs) of level 3 or higher, a second TCR-T cell reinfusion can be performed."

Trial Locations (1)

510000

RECRUITING

Sun Yat-sen Memorial Hospital, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER