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Study identifier: NCT05141474 Synced from ClinicalTrials.gov · July 29, 2026
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Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors

Condition: Epithelial Tumors, Malignant · Malignant Solid Tumor  ·  Sponsor: Vall d'Hebron Institute of Oncology

PhaseEARLY_Phase 1
Planned participants10
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Background: The presence of T-lymphocytes in resected tumor samples derived from long-term survival patients and the fact that reinvigoration of their functionality through the administration of specific immune-therapies can lead to remarkable antitumor responses supports that lymphocytes play a critical role in cancer immunity. Adoptive cell therapy using tumor-infiltrating lymphocytes product (TIL-ACT) is a well-established combination therapy currently under study in several world reference centers, using an autologous cell product without genetic modifications. This cell product consists of tumor-infiltrating lymphocytes (TIL), which are collected from the patient and expanded in the lab under specific conditions to enhance its antitumoral efficacy before reinfusion in the same patient. However, this cell product alone does not achieve adequate efficacy, and a combination of both previous non-myeloablative lymphodepleting (NMA-LD) chemotherapy and subsequent cytokine therapy (specifically IL-2) is needed to support the expansion of the infused cells. The investigators hypothesize that TILs enriched for neoantigen recognition are superior to unselected TILs at mediating tumor regression in patients with epithelial tumors and even other solid tumors where immune checkpoint blockade (ICB) is approved and used as part of standard therapy. The investigators propose to manufacture a T-cell product composed of TILs that are selected based on their ability to recognize patient…

This description comes directly from the study's public registry record.

Talk to the study team

Elena Garralda  ·  0034 93 489 30 00  ·  egarralda@vhio.net

Susana Muñoz  ·  smunoz@vhio.net

Always discuss trial participation with your own doctor first.

Locations (1)

Vall d'Hebron Institute of OncologyBarcelona, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT05141474