Synchronized autologous T-cell immunotherapy with hyperthermia to previously heavy treated advanced renal cell carcinoma.

PURPOSE: Immune checkpoint inhibitors (ICIs) and target therapy have provided the clinical efficacy for improving the clinical progression-free survival (PFS) and overall survival (OS) for patients with renal cell carcinoma (RCC). There has been little report of an surrogate salvage treatment for those failure of both ICIs and target. An innovation therapeutic model named SHAPE-T (synchronized hyperthermia with ex vivo autologous progenitor expanded T cells) was applied to previously heavily treated metastatic RCC (mRCC). The safety and clinical response with a three-year follow-up were filed. MATERIALS AND METHODS: This was N-of-1 clinical study describing such mRCC case with ECOG 3-4 score was treated by SHAPE-T. The peripheral blood apheresis was completed to produce ACT in vitro periodically .The nonimplantable in-depth hyperthermia device where the intratumor temperature could reach 42.5 C was performed for the average of 45 min, twice per week. One cycle ACT constituted three infusions of RetroNectin activated killer (RAK)cells at each 28 days interval. One SHAPE-T therapeutic schema included two cycles of 42.6 billion of RAKs plus 10 times of hyperthermia. The primary endpoints were PFS and OS. The clinical safety and efficacy of treatment cycles of infused T cells and therapeutic cycle were recorded. RESULTS: The enrolled patient was successfully recovered to complete response with OS exceeded 40 months. The ECOG performance recovered and sustained to score 0. There were less adverse reactions associated with SHAPE-T. CONCLUSIONS: The intractable and progressive mRCC could be salvaged by SHAPE-T. This was the first case that provide the insights into the importance of the SHAPE-T.

Duke Scholars

Author Herbert Kim Lyerly Surgery, Surgical Sciences

Author Michael Aaron Morse Medicine, Medical Oncology