T Cell Receptor Based Therapy of Metastatic Colorectal Cancer With mRNA-engineered T Cells Targeting Transforming Growth Factor Beta Receptor Type II (TGFβII)
Patients with advanced metastatic colorectal cancer who have no other effective treatment options will be offered the treatment. These patients have a poor prognosis, and there is a strong need for improved therapy. The patients will be given adoptive cell therapy (ACT) with Radium-1 TCR+ T cells transiently redirected against the TGFβRII frameshift antigen which is expressed in MSI+ colon cancer. The first report on TCR therapy in colon cancer was targeting carcinoembryonic antigen (CEA) where some evidence of clinical response was seen, but the T-cell function may have been inhibited due to the necessity to resolve the severe colitis which occurred due to the presence of CEA in normal cells in the colon. This demonstrates the feasibility of T-cell therapy in metastatic colon cancer, but also the limitations of targeting CEA as an antigen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
T cell receptor based therapy of metastatic colorectal cancer with mRNA-engineered T cells targeting mutant transforming growth factor beta receptor type II (TGFβII)
Oslo University Hospital
Oslo, Norway
Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0
Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0
Time frame: 2 years
Progression free survival (PFS)
PFS defined as time from treatment to objective progression (as assessed by RECIST v1.1)
Time frame: 2 years
Radiological response rate (ORR)
ORR defined as the proportion of patients with an objective tumor response
Time frame: 2 years
Overall survival (OS)
OS defined as time from treatment to date of death from any cause
Time frame: 2 years
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