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

Early Phase 1

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Biological: BEN101

• Registration Number: NCT05831033
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed Description

BEN101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with recurrent and/or metastatic solid tumor. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Last Update Submitted: 2023-04-14
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Study Start: 2023-05-15
• Primary Completion: 2026-02-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BEN101	BEN101	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.

Primary Outcome Measures

Name	Time	Method
Adverse Events (AE)	6 month	Adverse events according to CTCAE v5.0, Treatment Emergent Adverse event (TEAE) \>=grade 3; Treatment related adverse event (TRAE).

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR）	Up to 24 months	Proportion of patients with response per response to evaluate efficacy parameters such as Disease Control Rate (DCR) using RECIST v1.1 as assessed by the Investigator
Overall survival (OS)	Up to 24 months	The length of time from the date of the start of BEN101 treatment that the patients are still alive
Progression free survival (PFS)	Up to 24 months	The time length between BEN101 infusion and confirmed subsequent disease progression according to RECIST 1.1
Objective Response Rate (ORR)	Up to 24 months	Proportion of patients with response to evaluate efficacy parameters such as Objective Response Rate (ORR) using RECIST v1.1 as assessed by the Investigator
Duration of response (DOR)	Up to 24 months	To evaluate efficacy parameters such as Duration of Response (DOR) using RECIST v1.1 as assessed by the Investigator

Trial Locations

Locations (3)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

RenJi Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China