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.

CYAD-02 presented an higher engraftment and an improved clinical activity (17% objective response rate) compared to CYAD-01 (no objective response). Altogether, our data provide proof of principle that knock-down of MICA/B can enhance CAR T-cell persistence and efficacy while maintaining a good safety profile.

P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2025 --> Nov 2026

P1/2, N=52, Recruiting, Obsidian Therapeutics, Inc. | Trial completion date: Oct 2027 --> Jun 2028 | Trial primary completion date: Oct 2025 --> Jun 2028

The FDA approval of afamitresgene autoleucel for advanced synovial sarcoma and the breakthrough designation of letetresgene autoleucel for myxoid/round cell liposarcoma signify a major turning point...Tumour infiltrating lymphocyte therapy, including lifileucel, is under investigation with checkpoint inhibitors or oncolytic agents to enhance efficacy and manage toxicity...Challenges include HLA restriction, tumour heterogeneity, and manufacturing complexity. Future strategies involving novel antigens, multi-targeting, and combinatorial regimens could broaden patient eligibility and improve therapeutic outcomes.

These findings demonstrate the feasibility of ex vivo TIL expansion from EC tumors. This study provides a rationale for the initiation of the phase II clinical trial IOV-END-201 (NCT06481592) to evaluate lifileucel in patients with advanced EC.