ArticleFrontiers in immunology2026
Platform-based manufacturing of tumor-infiltrating lymphocytes derived from different solid tumor types.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: In adoptive cell therapy with tumor-infiltrating lymphocytes (TILs), TILs are isolated and expanded Objective: This study investigated whether a manufacturing process and control strategy developed for metastatic melanoma-derived TILs could be adapted into a tumor-agnostic platform for the generation of TILs from different solid tumor types, referred to as NTU101. Methods: The feasibility of generating TILs from endometrial carcinoma (ENDC, n=9), non-small cell lung cancer (NSCLC, n=9), and penile cancer (PENC, n=10) lesions was assessed during process development (PD) runs using predefined quality criteria. Throughout PD runs, flow cytometry was used to characterize cells. When available, autologous tumor digest was used to assess the tumor-reactive potential of TILs. Based on PD experience, adjusted quality criteria were applied to manufacture one full-scale GMP NTU101-drug product (DP) per tumor type. Results: Overall, 89% (n=25/28) of PD NTU101-DPs manufactured met the predefined quality criteria, containing at least 0.5×10^9 and 90% viable CD45+CD3+ cells, less than 1.0% of cellular impurities (viable CD45- and CD19+ cells), and a potency of more than 1.0×10^3 pg/mL IFN-γ secretion upon CD3/CD28-polymer stimulation. Across the tumor types, PD NTU101-DPs had comparable T-cell subset and differentiation state compositions. Conclusion: The NTU101 platform produced comparable NTU101-DPs from three solid tumor types beyond melanoma, with
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