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RECRUITING
NCT05831033
EARLY_PHASE1

Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

Multicenter, single arm, non-randomized, prospective, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (BEN101) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic solid tumor.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2023-05-23

Completion Date

2027-06-15

Last Updated

2024-09-19

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

BEN101

Lymphodepletion regimen:Cyclophosphamide 250mg/ m2/day x 3 days (day -4, -3,-2) , Fludarabine 25mg/ m2/day x 2 days (day-4, -3) , Paclitaxel 100mg/ m2/day -3. The lymphodepletion regimen could be adjusted by the treating physician according to patient's disease condition. BEN101 infusion: Single dose level between 1x10\^9 to 1x 10\^11,not lower than 1×10\^9 cells, final dose is affected by the starting amount of TILs cells isolated from the tumor tissue sample. IL-2:Administer 8-16 hr after TIL infusion. 600,000 IU/kg intravenously over 15-20 mins every 12 hours. It is recommended to start with high dose; and de-escalate based on tolerability, up to 5 days. IL-2 administration will be terminated if unacceptable toxicities occur.

Locations (3)

RenJi Hospital

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, China