Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:10 AM
Study NCT ID:
NCT06538012
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer
Sponsor:
Essen Biotech
Organization:
Study Overview
Official Title:
Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab Immunotherapy in Patients With Advanced or Metastatic Refractory Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAH2472
Brief Summary:
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.
Detailed Description:
Tumor-infiltrating lymphocytes (TILs) therapy is an innovative form of adoptive cell therapy that utilizes the patient's own immune cells to target and destroy cancer cells. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown remarkable efficacy in treating unresectable or metastatic melanoma. By extracting lymphocytes from the patient's tumor, expanding them ex vivo, and reinfusing them, Lifileucel has significantly improved the immune system's ability to combat cancer cells. This promising approach forms the basis for this study, which aims to apply similar methodologies to advanced or metastatic refractory lung cancer, a condition that generally has a poor prognosis and limited treatment options.
This trial involves several steps: initially, tumor samples are collected from patients for TIL extraction. Afterward, a lymphodepletion regimen using cyclophosphamide and fludarabine is administered to prepare the body for the infusion of expanded autologous TILs. Following the TIL infusion, Aldesleukin (IL-2) is administered to stimulate the TILs' activity. Pembrolizumab (Keytruda), an immunotherapy targeting the PD-1 receptor on T cells, is also given to further enhance the immune response against the tumor.
The primary goal of this trial is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and changes in the quality of life (QoL) of patients.
Patients will be closely monitored for side effects and reactions during their hospital stay and throughout the follow-up period. Safety will be assessed based on the incidence and severity of adverse events, while efficacy will be evaluated using RECIST v1.1 criteria. By leveraging the patient's own immune cells and combining them with advanced immunotherapies, this trial aims to provide a novel, personalized treatment option for patients with advanced or metastatic refractory lung cancer, building on the success observed with Lifileucel (Amtagvi) in melanoma treatment.
This trial involves several steps: initially, tumor samples are collected from patients for TIL extraction. Afterward, a lymphodepletion regimen using cyclophosphamide and fludarabine is administered to prepare the body for the infusion of expanded autologous TILs. Following the TIL infusion, Aldesleukin (IL-2) is administered to stimulate the TILs' activity. Pembrolizumab (Keytruda), an immunotherapy targeting the PD-1 receptor on T cells, is also given to further enhance the immune response against the tumor.
The primary goal of this trial is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and changes in the quality of life (QoL) of patients.
Patients will be closely monitored for side effects and reactions during their hospital stay and throughout the follow-up period. Safety will be assessed based on the incidence and severity of adverse events, while efficacy will be evaluated using RECIST v1.1 criteria. By leveraging the patient's own immune cells and combining them with advanced immunotherapies, this trial aims to provide a novel, personalized treatment option for patients with advanced or metastatic refractory lung cancer, building on the success observed with Lifileucel (Amtagvi) in melanoma treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: