T Cell Receptor Based Therapy of Metastatic Colorectal Cancer (TCR-CRC-001)
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|ClinicalTrials.gov Identifier: NCT03431311|
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: Adoptive Cell Therapy (ACT)||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protocol for Treatment Under Hospital Exemption: T Cell Receptor Based Therapy of Metastatic Colorectal Cancer With mRNA-engineered T Cells Targeting Transforming Growth Factor Beta Receptor Type II (TGFβII)|
|Actual Study Start Date :||March 8, 2018|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2024|
Experimental: Adoptive Cell Therapy (ACT)
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 [ Time Frame: 2 years ]Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0
- Progression free survival (PFS) [ Time Frame: 2 years ]PFS defined as time from treatment to objective progression (as assessed by RECIST v1.1)
- Radiological response rate (ORR) [ Time Frame: 2 years ]ORR defined as the proportion of patients with an objective tumor response
- Overall survival (OS) [ Time Frame: 2 years ]OS defined as time from treatment to date of death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431311
|Contact: Svein Dueland, MD PhD||+47 22 93 57 email@example.com|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0379|
|Contact: Svein Dueland, MD PhD 22934000 ext 47 firstname.lastname@example.org|
|Contact: Signe Fretland, CandPharm 22934714 ext 47 email@example.com|
|Principal Investigator:||Svein Dueland, MD PhD||Oslo University Hospital|