卡瑞利珠单抗联合或不联合自体细胞因子诱导的杀伤细胞治疗难治性透明细胞肾细胞癌的随机初步研究

Clear cell renal cell carcinoma (ccRCC) remains a challenging malignancy to treat, with immune checkpoint inhibitors (ICIs) revolutionizing patient management. This pilot study, evaluated the efficacy and safety of combination therapy comprising camrelizumab, an anti-PD-1 antibody, and autologous cytokine-induced killer (CIK) cell therapy in patients with refractory ccRCC. Twenty-one patients with refractory ccRCC were randomly assigned to receive either camrelizumab monotherapy (control group, n = 12) or camrelizumab combined with CIK cell re-transfusion (trial group, n = 9). Due to early termination (21 of 60 planned patients), all endpoints were exploratory. The objective response rate (ORR) was numerically higher in the combination group (55. 6% vs. 41. 7%; odds ratio 1. 75, 95% confidence interval [CI]: 0. 32-9. 51), but not statistically significant. Median progression-free survival (PFS) was 28.

5 vs. 8. 67 months (hazard ratio [HR] 0. 40, 95% CI: 0. 12-1. 34), and median overall survival (OS) was not reached vs. 57. 47 months (HR 0. 48, 95% CI: 0. 09-2. 53). One patient in the trial group achieved a complete metabolic response (CMR). The combination was well-tolerated without new safety signals. Exploratory analysis suggested that higher baseline PD-1 expression on CD8 + T cells might be associated with a better response, and the frequency of PD-1 positive cells tended to decrease after camrelizumab administration.

The addition of CIK cell therapy to anti-PD-1 antibody showed signals of potential benefit in refractory ccRCC with a tolerable safety profile. This pilot study suggests the combination approach appears feasible and warrants investigation in larger trials in pretreated ccRCC patients. Registry: ClinicalTrials. gov, TRN: NCT03987698, Registration date: 17 June 2019.