Dataset Information

Phase I study of immunopeptidome-guided personalized multi-peptide vaccines in chronic lymphocytic leukemia patients under BTK-inhibitor-based regimes

ABSTRACT: Cancer peptide vaccines hold promise as therapeutic approach, but their effectiveness has been hampered by lack of suitable antigens and the variability of HLA backgrounds among patients, which restricts their applicability.. We here introduce a novel warehouse concept for the construction of personalized peptide vaccines and outline its successful implementation in a Phase II clinical trial in patients with chronic lymphocytic leukemia (CLL) after first-line therapy. 20 CLL patients, in at least partial remission (PR) after treatment with Bruton’s tyrosine kinase inhibitors, were vaccinated with a personalized vaccine selected from a premanufactured immunopeptidome-defined CLL-associated peptide warehouse. Primary objective was immunogenicity, secondary objectives were safety and minimal residual disease (MRD) response. Immunopeptidome-guided vaccine composition was feasible throughout, confirming the success of warehouse-based vaccine design. Vaccination was well tolerated, with local injection site reactions the most common adverse events. Almost all patients showed vaccine-induced T cell responses, attributable to their inability to mount strong immune responses after immune-chemotherapy and the lack of potent adjuvant formulations. Both issues are addressed within a follow-up trial (NCT04688385), combining the here proven immunopeptidome-guided warehouse-based vaccine design with a strong novel adjuvant to evaluate personalized multi- peptide vaccination in CLL patients under T cell supportive BTK inhibitor therapies.

INSTRUMENT(S):

ORGANISM(S): Homo Sapiens (human)

TISSUE(S): Peripheral Blood Mononuclear Cell, Blood

DISEASE(S): Chronic Lymphocytic Leukemia

SUBMITTER: Marcel Wacker

LAB HEAD: Juliane Sarah Walz

PROVIDER: PXD059004 | Pride | 2026-01-22

REPOSITORIES: Pride

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Dataset's files

Source:

			Action	DRS
	210518_CLL-XS15-I-01-03_class_II_SequestOT_3Reps_coprocessed.msf	Msf
	210518_CLL-XS15-I-01-03_class_I_SequestOT_3Reps_coprocessed.msf	Msf
	210518_iVAC_CLL-XS15-I-01-03_Tue39L243_20_Rep1_DDA_400-1000mz_msms56.raw	Raw
	210518_iVAC_CLL-XS15-I-01-03_Tue39L243_20_Rep2_DDA_400-1000mz_msms57.raw	Raw
	210518_iVAC_CLL-XS15-I-01-03_Tue39L243_20_Rep3_DDA_400-1000mz_msms58.raw	Raw

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Publications

Personalised multipeptide-based T-cell activator for chronic lymphocytic leukaemia: an open-label, single-centre, phase 1 study.

Heitmann Jonas S JS Maringer Yacine Y Jung Susanne S Wacker Marcel M Hackenbruch Christopher C Polster Mark M Marconato Maddalena M Nelde Annika A Bauer Jens J Zwick Melissa M Baur Anna-Sophia AS Lehmann Ariane A Krolla Christopher C Andrieux Geoffroy G Köhler Natalie N Boerries Melanie M Denk Monika M Zieschang Lisa L Kammer Christine C Hoenisch-Gravel Naomi N Richter Marion M Oezbek Melek Tutku MT Wirths Stefan S Dengler Anna A Dubbelaar Marissa L ML Pumptow Marina M Martus Peter P Brüggemann Monika M Rammensee Hans-Georg HG Salih Helmut R HR Walz Juliane S JS

The Lancet. Haematology 20260114

<h4>Background</h4>Therapeutic T-cell activation to induce tumour-specific immune responses promises sustainable cancer control. However, this treatment is not yet widely used because of the challenges of personalised drug design and a shortage of mutation-derived neoepitopes. This study aimed to evaluate the immunogenicity, safety, and toxicity of iTAC-XS15-CLL01, a personalised warehouse-based multipeptide T-cell activator combined with the Toll-like receptor 1/2 ligand XS15, in patients with ...[more]

PMID: 41547362

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