drugset / Trial / NCT05831033
Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors
Phase 0
Recruiting
16 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University · collabRenJi Hospital · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-05-23
- Primary completion
- 2027-02-15
- Completion
- 2027-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BEN101 | Unknown | 1e+09 cells | — |
| Subject | BEN101 | Unknown | 1e+11 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Background | aldesleukin | Protein / enzyme biologic | 600000 iu/kg | Intravenous |