Status:
TERMINATED
T Cell Receptor Based Therapy of Metastatic Colorectal Cancer
Lead Sponsor:
Oslo University Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
T Cell Receptor Based Therapy of Metastatic Colorectal Cancer With mRNA-engineered T Cells Targeting Transforming Growth Factor Beta Receptor Type II (TGFβII)
Detailed Description
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 im...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with metastatic colon cancer which is MSI+ with the presence of the -1A deletion in TGFβRII gene, and positive for HLA-A02 genotype
- Measurable disease
- Female or male patients. Fertile females must have a negative pregnancy test before inclusion in the trial. Both fertile men and women must be ready and able to use highly effective methods of contraception, defined as use of oral, implanted, injectable, and mechanical or barrier products for the prevention of pregnancy during participation of the trial
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
- Age 18 years and older
- Life expectancy of at least 3 months
- Signed informed consent (by the subject or subject's legal representative) obtained before any trial-related procedures.
- Adequate organ function, measured by pre-defined laboratory values
- Exclusion criteria
- Other metastatic malignancies
- Any other anti-tumour treatment within 4 weeks prior to first administration of cells.
- Steroid treatment, except substitution dose
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina or serious cardiac arrhythmia
- Active infection requiring antibiotic therapy
- Pregnancy or lactation
- Known hypersensitivity to any of the components of the investigational product
- Patients who test positive for hepatitis B, C, HIV or syphilis
- Any reason why, in the opinion of the investigator, the patient should not participate
Exclusion
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03431311
Start Date
March 8 2018
End Date
June 12 2019
Last Update
June 13 2019
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0379