A Phase 1/2 interventional study of Adoptive Cell Therapy (ACT) in Colorectal Cancer, sponsored by Oslo University Hospital. Terminated at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-13.
Sponsored by Oslo University Hospital · Phase 1/2, Interventional, and Treatment
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.
Exclusion criteria
The ACT will be administered as two intravenous (i.v.) injections of GMP TCR T cells per week for 6 weeks. Escalating dose per week, from 1 x108 cells (week 1) to 2x109 cells (week 4 onwards) using a central venous catheter. The doses listed indicate the maximum number of T cells per injection at any given time point.
Biological: Adoptive Cell Therapy (ACT)
T cell receptor based therapy of metastatic colorectal cancer with mRNA-engineered T cells targeting mutant transforming growth factor beta receptor type II (TGFβII)
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
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oslo University Hospital