A phase I/II clinical trial (NCT00834002) to evaluate the feasibility, safety, and efficacy of intradermal vaccination with autologous dendritic cells (DC) transfected with Wilms’ tumor antigen-1 (WT1) mRNA in acute myeloid leukemia (AML) patients.

A phase II clinical trial (NCT00965224) to evaluate the clinical efficacy of autologous Wilms’ tumor antigen-1 (WT1)-targeted dendritic cell (DC) vaccination as a postremission therapy in patients with acute myeloid leukemia (AML) at very high risk of relapse.

A single-arm phase I/II clinical study (NCT01291420) to evaluate the feasibility, safety, immunogenicity, and clinical efficacy of autologous Wilms’ tumor antigen-1 (WT1)-targeted dendritic cell (DC) vaccination in 40 patients with poor-prognosis advanced solid tumors, including glioblastoma multiforme, breast cancer, malignant pleural mesothelioma, and other solid tumor types receiving standard therapy.

A phase II clinical trial (NCT01686334) to confirm whether autologous Wilms’ tumor antigen-1 (WT1)-transfected dendritic cell (DC) vaccination can eliminate minimal residual disease, reduce relapse rates, and improve overall survival compared with standard follow-up alone in 138 acute myeloid leukemia (AML) patients, including a control group.

A single-arm, single center phase I/II clinical trial (NCT02649582 ; EUCT 2024-515291-13-00) to evaluate overall and progression-free survival in newly diagnosed glioblastoma patients (WHO grade IV) treated with autologous Wilms’ tumor antigen-1 (WT1)-transfected dendritic cell (DC) vaccination in combination with standard of care, being chemoradiation with temozolomide followed by temozolomide maintenance, and to assess the feasibility, safety, and immunogenicity of this approach.

A phase I/II clinical trial (NCT04911621 ; EUCT 2024-515295-12-00 to assess the feasibility, safety, and immunogenicity of autologous Wilms’ tumor antigen-1 (WT1)-transfected dendritic cell (DC) vaccination in pediatric patients with high-grade gliomas (HGG) and diffuse intrinsic pontine gliomas (DIPG), and to evaluate its impact on clinical outcomes and quality of life compared with standard treatments.

A single-arm phase I/II clinical trial (NCT02649829 ; EUCT 2024-517970-35-00) to evaluate the safety, feasibility, and immunogenicity of autologous Wilms’ tumor antigen-1 (WT1)-transfected dendritic cell (DC) vaccination in patients with histologically confirmed epithelial malignant pleural mesothelioma (MPM), and to assess its impact on clinical outcomes, including time-to-progression, progression-free and overall survival, when combined with standard chemotherapy and, when applicable, surgery.

A multicenter single-arm phase I/II clinical trial (NCT05765084 ; EUCT 2024-515293-27-00) to evaluate the feasibility and safety of combining first-line platinum/pemetrexed chemotherapy with the PD-L1 inhibitor atezolizumab and autologous Wilms’ tumor antigen-1 (WT1)-transfected dendritic cell (DC) vaccination in patients with histologically confirmed, unresectable epithelioid malignant pleural mesothelioma (MPM), and to assess the immunogenicity and clinical benefit of this integrated chemo-immunotherapy approach.

A phase I/II clinical trial (NCT05964361 ; EUCT 2024-515296-35-00) to evaluate the safety and immunogenic potential of a next-generation autologous Wilms’ tumor antigen-1 (WT1)-transfected dendritic cell (DC) vaccine engineered for IL-15 transpresentation in patients with refractory or advanced solid tumors, and to determine whether this modification enhances antitumor immune responses against WT1-expressing cancer cells.

A phase I clinical trial (NCT02618902) to evaluate the safety and preliminary proof of concept of autologous vitamin D3–treated tolerogenic dendritic cells (tolDC) loaded with myelin-derived peptides in patients with multiple sclerosis, and to assess their potential to restore immune tolerance and counteract autoimmune responses against myelin.

a confirmatory EU-based trial to investigate the safety and efficacy of varnimcabtagene autoleucel (var-cel), an in-house produced CAR T-cell therapy for adult patients with relapsed refractory acute lymphoblastic leukemia (R/R ALL), in order to gain centralised approval in the EU via the European Medicines Agency (EMA). This study is supported by an international alliance of cancer funds and is conducted in academic centres from 5 different EU countries (Spain, France, Belgium, Austria, and the Netherlands)outcomes.

An open-label, self-controlled, multicenter phase IIa clinical trial (NCT07020715) to evaluate the efficacy and safety of autologous vitamin D3–treated tolerogenic dendritic cells (tolDC) loaded with myelin-derived peptides in patients with progressive multiple sclerosis, and to assess their capacity to induce sustained immune tolerance and improve clinical and radiological outcomes.

A phase I/II clinical trial (EUCT 2022-502661-23-00) to evaluate the safety, efficacy, and feasibility of decentralized manufacturing of GLPG5101 (Galapagos NV), a second-generation anti-CD19/4-1BB CAR-T therapy, in patients with high-need hematological malignancies, and to determine the recommended Phase 2 dose and the Objective Response Rate.

An open-label, multicenter phase I/II clinical trial (EUCT 2022-500782-27-00) to evaluate the safety, feasibility, and efficacy of GLPG5301 (Galapagos NV), a second-generation BCMA-directed CAR-T therapy, with 4-1BB costimulation, in patients with relapsed/refractory multiple myeloma after at least 2 prior therapies, and to determine the recommended Phase 2 dose, and assess the performance of an innovative point-of-care manufacturing platform.

A phase I clinical trial (EUCT 2023-507820-22-00) to evaluate the safety and tolerability of BMS-986353 (Celgene Corp), a CD19-directed CAR T-cell therapy manufactured using the NEX-T process, in patients with relapsing and progressive multiple sclerosis, to determine the recommended Phase 2 dose, and to explore its potential to provide durable, treatment-free disease control through immunomodulation.

A phase III clinical trial (NCT06413498) to compare Anitocabtagene Autoleucel (Anito-cel), an autologous anti-B-cell maturation antigen (BCMA) CAR-T-cell therapy (Kite, a Gilead Company) to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug.

A phase III Randomized, Open-Label, Multicenter Study (NCT06615479) to compare the efficacy and safety of Arlocabtagene Autoleucel (arlo-cel), a GPRC5D-directed CAR-T Cell Therapy, (BMS-986393, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.

A integrated phase II/III trial (EUCT 2022-501050-11-01) to optimize treatment for patients with acute lymphoblastic leukemia (ALL) by using a harmonized European protocol to safely de-escalate therapy in low-risk patients and intensify treatment for high-risk patients, while identifying those who may benefit from innovative approaches such as CAR-T therapy.