MedTrace Logo

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

NCT05831033 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-09-19

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

    collaborator UNKNOWN

  • RenJi Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Hongxia Wang, Doctor · Shanghai General Hospital, Fudan University Shanghai Cancer Center

  • Wen Di, Doctor · RenJi Hospital

  • Wei Xue, Doctor · RenJi Hospital

  • Weiyi Huang, Master · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2027-02-15
Completion
2027-06-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831033 on ClinicalTrials.gov