histologically or cytologically confirmed solid tumor of the pancreas, esophagus, liver or ovaries that is advanced, recurrent or progressing after at least first-line anti-cancer treatment, or for which no alternative standard therapy is available due to intolerance to or refusal of standard-of-care treatment. MedDRA version: 20.0 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 100000004865 MedDRA version: 21.0 Level: LLT Classification code 10048683 Term: Advan
Conditions
Interventions
Product Name: IL15-transpresenting WT1-targeted Dendritic cells
Product Code: WT1/IL15/IL15Ra mRNA DC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: WT1/IL15/IL15Ra mRNA DC
Curren
Sponsors
Antwerp University Hopsital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis with a histologically or cytologically confirmed solid tumor of the pancreas, esophagus, liver or ovaries that is advanced, or recurrent or progressing after at least first-line anti-cancer treatment, or for which no alternative standard therapy is available due to intolerance to or refusal of standard-of-care treatment. - At least 1 measurable or evaluable lesion as defined by the latest version of Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria. - Reasonable life expectancy of at least 3 months (in the Investigator’s opinion) - Aged = 18 years at the time of signing informed consent - World Health Organization (WHO) performance status 0-2 - Adequate hematologic and end-organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: - Use of any investigational agent within 4 weeks before the planned day of leukapheresis - Active or history of autoimmune disease or immune deficiency - Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and safety of IL-15-transpresenting WT1-targeted DC vaccine production and administration in patients with advanced or refractory solid tumors.;Secondary Objective: - To assess indicators of clinical efficacy of vaccination with IL-15-transpresenting WT1-targeting DCs in patients with advanced or refractory solid tumors - To determine the in vivo immunogenicity of IL-15-transpresenting WT1-targeting DC vaccination in patients with advanced or refractory solid tumors - To document and characterize changes in general and disease-specific quality of life using EQ-5D-5L and QLQ-C30 questionnaires at predefined time points. ;Primary end point(s): (i) Feasibility - proportion of patients that had a successful leukapheresis - proportion of patients that had successful vaccine production and meeting all quality control measurements - proportion of patients who complete the study treatment schedule within the timeline schedule proposed in the study protocol (ii) Safety Occurrence of AEs and SAEs during IL-15-transpresenting WT1-targeting DC vaccine administration and during follow-up - Proportions of patients in the safety population that experienced AEs, SAEs possibly, probably or definitely related to IL-15-transpresenting WT1-targeting DC vaccination - Number and grade of AEs and SAEs in the safety population ;Timepoint(s) of evaluation of this end point: Safety evaluation for proceeding into an expansion cohort will be done as soon as possible after the safety-limiting adverse event (SLAE) reporting period of the last included patient of the safety cohort has ended (i.e. 24 hours post V6) and will be based on the occurrence of SLAEs, according to a best of five design. At the end of study (i.e. 90 days after final IL-15-transpresenting WT1-targeting DC vaccine administration of the last included patient), data for feasibility and safety will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (i) Clinical efficacy - best overall response - the duration of response for patients with OR - overall response rate - disease control rate - progression-free survival - overal survival (ii) immunogenicity, including but not restricted to: - functional WT1-specific T cell responses (iii) quality of life - how patients experience the study therapy, - how patient-reported disease-related symptoms evolve over time - how patient-reported quality of life evolves over time ;Timepoint(s) of evaluation of this end point: At the end of study (i.e. 90 days after final IL-15-transpresenting WT1-targeting DC vaccine administration of the last included patient), data for clinical efficacy, immunogenicity and quality of life will be evaluated. | — |
Countries
Belgium
Contacts
Public ContactCCRG
Antwerp University Hospital
Outcome results
None listed