Efficacy and Safety of Prophylactic Use of Peg-Rhg-CSF before CAR-T Cell Infusion in MM Patients

Background:Infection caused by leukopenia is an important complication of CAR-T cell therapy, and there is no unified consensus on the use of CSF during CAR-T therapy. It is not clear whether the prophylactic use of PEG-rhG-CSF can alleviate leukopenia and reduce the chance of infection, or whether it may increase the risk of CRS and ICANS. Aims:We explore the efficacy and safety of prophylactic use of PEG-rhG-CSF before CAR-T cell reinfusion in MM patients, in order to provide some data support for the application of PEG-rhG-CSF in CAR-T cell therapy. Methods:We studied 30 patients with MM who received anti-BCMA CAR-T cell or anti-BCMA and CD19 CAR-T cell therapy (ChiCTR2000033567). Patients received FC pretreatment from days -4 to -1 and were infused with 1-2*106/Kg CAR-T cells. Among them, 11 patients received PEG-rhG-CSF 3-6 mg on day 0, and 19 patients did not receive PEG-rhG-CSF. The response status, incidence of CRS and ICANS, incidence and duration of neutropenia and agranulocytosis, and antibiotic use of the two groups were analyzed. Results:There was no significant difference in the remission rate above VGPR within 3 months after reinfusion between the PEG group and the non-PEG group (72.73% vs. 78.95%, p=1.000). The incidence of CRS in the two groups was 1 case in stage I, 1 case in stage II, 1 case in stage III, and 1 case in stage IV in the PEG group, and 2 cases in stage II and 1 case in stage IV in the non-PEG group. ICANS occurred in 1 case in each group. There was also no significant difference in the incidence of neutropenia (90.91% vs.100%, p=0.367). The incidence of agranulocytosis in PEG group was significantly reduced (27.27% vs. 73.68%, p=0.023), and the duration of agranulocytosis was significantly shorter than that in the control group (mean 1.36 vs. 5.89, p=0.013). There was no significant difference in the antibiotic usage rate (63.64% vs. 73.68%, p=0.687), which included preventive drugs such as SMZ-CO and acyclovir. Conclusion:This study showed that the prophylactic use of PEG rhG CSF in MM patients before CAR-T cell therapy could shorten the degree and duration of neutropenia without aggravating the occurrence of CRS, and reduce the risk of severe infection. This provides certain data support for guiding the application of PEG-rhG-CSF in CAR-T cell therapy for MM patients.