OncoMatch/Clinical Trials/NCT05141474
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
Is NCT05141474 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including NEXTGEN-TIL and Non-myeloablative Lymphodepletion (NMA-LD) Regimen for epithelial tumors, malignant.
Treatment: NEXTGEN-TIL · Non-myeloablative Lymphodepletion (NMA-LD) Regimen · Interleukin-2 — 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-specific neoantigens and to use these to treat patients with metastatic, refractory, epithelial cancers, as well as ICB-resistant solid tumors. Furthermore, it also proposed to study the tumor and T cells at baseline and after treatment to investigate whether specific phenotypic and functional traits may be associated with clinical outcome. Primary objective: To evaluate the safety and the tolerability of ex vivo next generation neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) in patients with metastatic or unresectable epithelial tumors and immune checkpoint blockade (ICB) resistant solid tumors. Secondary objectives: * To determine the success in producing active specific TILs from our target patients. * To evaluate the initial clinical activity of the NEXTGEN-TIL products in our target patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor — for tumors where ICB is approved
at least one prior line with ICB for the group of patients with tumors where ICB is approved
Cannot have received: investigational cell or gene therapy
Patients who have previously received any investigational cell or gene therapies
Lab requirements
Blood counts
Haemoglobin ≥9.0 g/dL; ANC ≥1000/mm3 without filgrastim; platelets ≥100 x10⁹/mm3; PT and aPTT ≤1.5 x ULN (unless on therapeutic anticoagulation)
Kidney function
Serum creatinine <1.5 mg/dL or measured creatinine clearance ≥50 ml/min (Cockcroft-Gault)
Liver function
AST or ALT ≤3 x ULN (≤5 x ULN with liver metastases); total bilirubin <2 mg/dL (≤3 mg/dL with Gilbert's Syndrome)
Cardiac function
LVEF ≥45%
Patients with documented left ventricular ejection fraction (LVEF) of ≥45%. ... adequate hematological, renal and hepatic functions defined by: Haemoglobin ≥9.0 g/dL. An absolute neutrophil count ≥1000/mm3 without the support of filgrastim. Platelets ≥ 100 x10⁹ /mm3. PT and aPTT ≤1.5 x upper limit of normal (ULN, unless receiving therapeutic anticoagulation). ... AST or ALT ≤3 x ULN. Patients with liver metastases must have AST and ALT ≤5.0 x ULN. Total bilirubin <2 mg/dL. Patients with Gilbert's Syndrome must have a total bilirubin ≤3.0 mg/dL. Serum creatinine <1.5 mg/dL or measured creatinine clearance ≥50 ml/min calculated using the Cockcroft-Gault glomerular filtration rate estimation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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