Objective To explore the efficacy and safety of a novel adoptive T cell therapy induced by PD-1 mAb, IL-2, and IL-15 in treatment with the solid tumors.

Methods A single center, prospective, exploratory phase Ⅰ study was conducted. Patients with advanced solid tumors had undergone a novel T-cell therapy alone or the novel T-cell therapy combined with treatment from March 2018 to December 2020 in Zhongshan Hospital, Fudan University. The primary index was safety, such as the incidence and severity of adverse effects. Secondary index was effectiveness, including quality of life scores and progression free survival. And the change of immune status of patients during treatment was analyzed.

Results Ten patients were enrolled, including 3 patients with hepatocellular carcinoma, 5 with intestinal tumor, 1 with pancreatic cancer, and 1with lung cancer. No treatment-related severe adverse events occurred within 28 days after cell infusion. The qualities of life of all patients were improved after cell therapy, especially in improvement of somatic function, general health, tiredness (P < 0.05). Disease progressed in all 3 patients treated with novel T-cell therapy alone. The disease control rate in patients treated with combined therapy was 71.4%. In the nonresponse patients underdoing combined treatment, the percent of Treg in peripheral blood was higher than that in response patients (baseline: P=0.06, 28-days after treatment: P=0.03).

Conclusions Novel autologous T cells generated by PD-1 mAb, IL-2, and IL-15 induction, are safe and manageable and show some anti-tumor effects. The combination of novel autologous T cells and standard therapy has shown good efficacy.