First-in-human interleukin-15-transpresenting Wilms’ tumor protein 1-targeting autologous dendritic cell vaccination in cancer patients

Phase 1/2

Active, not recruiting

Conditions: 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

Registration Number: 2024-515296-35-00

Lead Sponsor: Antwerp University Hospital

Brief Summary: 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

Detailed Description: The investigational medicinal product concerns dendritic cells that were engineered to target the tumor antigen Wilms' Tumor-1 (WT1) and in addition transpresent the cytokine IL15 on their cell surface. By inclusion of the IL15-transpresentation mechanism, the intention is to render the dendritic cell more immunogenic (i.e. they have a higher capacity to stimulate the immune system to recognize and attack WT1-expressing cancer cells).

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 10

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

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility based on (A) proportion of patients that had a successful leukapheresis, (B) proportion of patients that had successful vaccine production and meeting all quality control measurements and (C) proportion of patients who complete the study treatment schedule within the timeline schedule proposed in the study protocol		Feasibility based on (A) proportion of patients that had a successful leukapheresis, (B) proportion of patients that had successful vaccine production and meeting all quality control measurements and (C) proportion of patients who complete the study treatment schedule within the timeline schedule proposed in the study protocol
Safety, based on the occurrence of AEs and SAEs during IL-15-transpresenting WT1-targeting DC vaccine administration and during follow-up: (A) Proportions of patients in the safety population that experienced AEs, SAEs possibly, probably or definitely related to IL-15-transpresenting WT1-targeting DC vaccination, (B) Number and grade of AEs and SAEs in the safety population		Safety, based on the occurrence of AEs and SAEs during IL-15-transpresenting WT1-targeting DC vaccine administration and during follow-up: (A) Proportions of patients in the safety population that experienced AEs, SAEs possibly, probably or definitely related to IL-15-transpresenting WT1-targeting DC vaccination, (B) Number and grade of AEs and SAEs in the safety population

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy: (A) best overall response (B) the duration of response for patients with OR (C) overall response rate (D) disease control rate (E) progression-free survival (F) overal survival		Clinical efficacy: (A) best overall response (B) the duration of response for patients with OR (C) overall response rate (D) disease control rate (E) progression-free survival (F) overal survival
Immunogenicity, including, but not restricted to, functional WT1-specific T cell responses		Immunogenicity, including, but not restricted to, functional WT1-specific T cell responses
Quality of life: (A) how patients experience the study therapy, (B) how patient-reported disease-related symptoms evolve over time, (C) how patient-reported quality of life evolves over time		Quality of life: (A) how patients experience the study therapy, (B) how patient-reported disease-related symptoms evolve over time, (C) how patient-reported quality of life evolves over time

Trial Locations

Locations (1): Antwerp University Hospital
🇧🇪
Edegem, Belgium
Antwerp University Hospital
🇧🇪Edegem, Belgium
Timon Vandamme
Site contact
003238213250
Timon.Vandamme@uza.be