Tha aim of this clinical trial is to evaluate safety and tolerability of autologous peripheral blood differentiated and matured adult dendritic cells. Immunogenicity of the prduct(DC-DELAY) will be evaluated also.
First in human, pilot, open-label, prospective, single-site, non-randomised study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Autologous peripheral blood differentiated and matured adult dendritic cells loaded with Frameshift-derived neopeptides (FSDN) (DC-DELAY). Eligible participants will receive six intradermal immunizations of DC-DELAY at week 0, 2, 4, 6, 8 and 10.
Laura Burunat
Barcelona, Barcelona, Spain
RECRUITINGProportion of participants with grade 3-4 related adverse events for 12 months following the first immunization.
To evaluate the safety and tolerability of autologous peripheral blood differentiated and matured adult dendritic cells loaded with frameshift derived neopeptides (DC-DELAY) in LS carriers.
Time frame: the first 12 month after the last inmunization
Proportion of participants with specific frameshift-derived neoantigens immune response induced by DC-DELAY as measured in peripheral blood by enzyme-linked immune absorbent spot(ELISpot) assay at week 12.
To evaluate specific frameshift-derived neoantigens immunogenicity of DC-DELAY in LS carriers at week 12. NOTE: Immune response will be defined as T-cell reactivity to at least 1 out of 4 of the pools.
Time frame: At week 12.
Proportion of participants with early immune response induced by DC-DELAY as measured inperipheral blood by ELISpot assay at week 6.
To evaluate the early-term specific frameshift-derived neoantigens immunogenicity of DC-DELAY in LS carriers at week 6.
Time frame: Week 6
Proportion of participants with long term immune response induced by DC-DELAY as measured in peripheral blood by ELISpot assay at months 6, 12 and 24.
To evaluate the long-term specific frameshift-derived neoantigens immunogenicity of DC-DELAY in LS carriers at 6, 12 and 24 months.
Time frame: Month 6, 12 and 24.
Proportion of participants with immune response induced by DC-DELAY as measured in the normal colonic mucosa at month 12.
To evaluate the specific frameshift-derived neoantigens immunogenicity of DC-DELAY in the normal colonic mucosa in LS carriers at month 12.
Time frame: Month 12
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Proportion of participants with mismatch repair deficient colorectal adenomas, advanced neoplasia and/or carcinoma throughout the study duration.
To evaluate the effect of DC-DELAY in LS carriers at week 12 on the burden of mismatch repair deficient colorectal neoplasia throughout the study duration.
Time frame: Month 12 and month 36
Proportion of participants with LS-related carcinomas throughout the study duration (36 months).
To evaluate the effect of DC-DELAY immunization in LS carriers at week 12 on the burden of LSrelated carcinomas throughout the study duration.
Time frame: Week 12 and month 36
Number and proportion of participants with related adverse events at 7 days after each DC-DELAY immunization.
To evaluate the safety and tolerability of DC-DELAY
Time frame: 7 days after each iminization, week 0, week 2, week 4, week 6, uweek 8 and week 10.
Number and proportion of participants with grade 3-4 related adverse events throughout the study duration (36 months).
To evaluate the safety and tolerability of DC-DELAY throughout the study duration.
Time frame: Through study completion, an average of 3 years.