Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-28 @ 4:09 PM
Study NCT ID:
NCT06530303
Status:
RECRUITING
Last Update Posted:
2024-11-05
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer
Sponsor:
Essen Biotech
Organization:
Study Overview
Official Title:
Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Immunotherapy in Patients With Advanced or Metastatic Refractory Colon and Rectal Cancer (Colorectum)
Status:
RECRUITING
Status Verified Date:
2024-11
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:
BAH248
Brief Summary:
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (interleukin-2, IL-2) immunotherapy in patients with advanced or metastatic refractory colon and rectal cancer (colorectum). 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, while Aldesleukin will be used to further stimulate the TILs. 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 provide a novel, personalized treatment option for patients with limited therapeutic alternatives.
Detailed Description:
Tumor-infiltrating lymphocytes (TILs) therapy is an advanced form of adoptive cell therapy that harnesses the patient's immune cells to fight cancer. This therapy involves extracting lymphocytes from the tumor, expanding them ex vivo, and reinfusing them into the patient to target and kill cancer cells. This study focuses on combining TIL therapy with Pembrolizumab (Keytruda) and Aldesleukin (IL-2) to enhance the anti-tumor immune response in patients with advanced or metastatic refractory colon and rectal cancer (colorectum), conditions that typically have a poor prognosis and limited treatment options.
This trial involves a multi-step treatment process. First, tumor samples are collected from patients for TIL extraction. Following this, a lymphodepletion regimen using cyclophosphamide and fludarabine is administered to prepare the body for the infusion of expanded autologous TILs. After the TIL infusion, Aldesleukin (IL-2) is given to stimulate the TILs' activity. Pembrolizumab (Keytruda), an immunotherapy that targets the PD-1 receptor on T cells, is also administered 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 colon and rectal cancer.
This trial involves a multi-step treatment process. First, tumor samples are collected from patients for TIL extraction. Following this, a lymphodepletion regimen using cyclophosphamide and fludarabine is administered to prepare the body for the infusion of expanded autologous TILs. After the TIL infusion, Aldesleukin (IL-2) is given to stimulate the TILs' activity. Pembrolizumab (Keytruda), an immunotherapy that targets the PD-1 receptor on T cells, is also administered 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 colon and rectal cancer.
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?: