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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Antwerp University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Phenomena and Processes [G] - Immune system processes [G12], Diseases [C] - Neoplasms [C04]

Trial duration

6 Dec 2023 → 22 Sep 2025

Decision date (initial)

2024-11-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2024-515296-35-00

EudraCT number

2020-004124-42

ClinicalTrials.gov

NCT05964361

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

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 objectives 3

1. To assess indicators of clinical efficacy of vaccination with IL-15-transpresenting WT1-targeting DCs in patients with advanced or refractory solid tumors
2. To determine the in vivo immunogenicity of IL-15-transpresenting WT1-targeting DC vaccination in patients with advanced or refractory solid tumors
3. 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

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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
2. At least 1 measurable or evaluable lesion as defined by the latest version of Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria
3. Reasonable life expectancy of at least 3 months (in the Investigator’s opinion)
4. Aged ≥ 18 years at the time of signing informed consent
5. World Health Organization (WHO) performance status 0-2
6. Adequate hematologic and end-organ function

Exclusion criteria 3

1. Use of any investigational agent within 4 weeks before the planned day of leukapheresis
2. Active or history of autoimmune disease or immune deficiency
3. Pregnancy or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. 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 endpoints 3

1. 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
2. Immunogenicity, including, but not restricted to, functional WT1-specific T cell responses
3. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Antwerp University Hospital

Sponsor organisation

Antwerp University Hospital

Address

Drie Eikenstraat 655

City

Edegem

Postcode

2650

Country

Belgium

Scientific contact point

Organisation

Antwerp University Hospital

Contact name

Center for Cell Therapy and Regenerative Medicine

Public contact point

Organisation

Antwerp University Hospital

Contact name

Center for Cell Therapy and Regenerative Medicine

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications