P1, N=2, Active, not recruiting, Richard Wu | Trial completion date: Dec 2025 --> Dec 2026

Here, we report the successful generation and expansion of TIL engineered with regulatable, membrane-bound IL15 (cytoTIL15™ cells) from immune-excluded, paucicellular chondrosarcoma biopsies largely consisting of collagenous matrix and demonstrate that these cells have potent tumor-killing capacity in cell culture and in tumor spheroid models in the absence of exogenous IL2...Moreover, we demonstrate that IL15 reduced the signaling threshold of T-cell receptors isolated from TIL clonotypes, increasing their infiltration and cytotoxicity in autologous 3D tumor models. These results suggest the possibility of developing an effective IL2-free TIL therapy for patients with immune-excluded tumors.

The 2024 FDA approval of Lifileucel (Amtagvi), a commercially manufactured autologous TIL product, marks a key milestone in integrating advanced therapy medicinal products (ATMPs) into routine care for solid tumours...A nationally coordinated effort is required to harmonise clinical prioritisation strategies, maintain oversight by multidisciplinary specialist tumour boards, and consider investment in future-proof decentralised manufacturing capacity. Collaborations and peer support such as through the Advanced Therapy Treatment Centre (ATTC) Network will facilitate phased, experience-led rollout with equity-focused service design.

P1/2, N=69, Not yet recruiting, Iovance Biotherapeutics Inc.

P1, N=30, Recruiting, Memorial Sloan Kettering Cancer Center | N=20 --> 30

P1, N=9, Completed, Xinqiao Hospital of Chongqing | Unknown status --> Completed | N=20 --> 9

This constituted only the second approval of a cell therapy in a solid tumor following lifileucel in melanoma and demonstrated the potential of cell therapies in sarcomas...However, the broader application of these therapies is hindered by the lack of targetable sarcoma-restricted immunogenic epitopes, spatiotemporal intratumoral heterogeneity, and a profoundly immunosuppressive tumor microenvironment that impedes effector-cell trafficking, expansion and persistence. While cell therapies hold promise for integration into precision medicine approaches for sarcomas, their successful implementation will require careful evaluation of clinical feasibility, logistical considerations and cost-effectiveness to optimize patient outcomes.

P1, N=7, Completed, Iovance Biotherapeutics, Inc. | Phase classification: P1/2 --> P1

P1/2, N=40, Recruiting, Cabaletta Bio | Phase classification: P1 --> P1/2

P2, N=100, Recruiting, Iovance Biotherapeutics, Inc.

P1, N=32, Active, not recruiting, Baylor College of Medicine | Trial primary completion date: Oct 2025 --> Jan 2026

P2, N=92, Terminated, Marker Therapeutics, Inc. | N=47 --> 92 | Completed --> Terminated; Despite a plan to enroll ~195-210 participants, the ARTEMIS study was closed due to the long vein-to-vein manufacturing timeline of MT-401 after 38 participants received the autologous MT-401.