Data are scarce regarding both safety and immunogenicity of the BNT162b2 mRNA COVID-19 vaccine in patients undergoing immune cell therapy, thus we prospectively evaluated these 2 domains in patients receiving this vaccine after allogeneic HCT (n=66) or after CD19-based CART therapy (n=14). Overall, vaccine was well tolerated, with mild non-hematologic vaccine-reported adverse events in minority of the patients. 12% (after first dose) and 10% (after second dose) of the patients developed cytopenia and there were 3 cases GVHD exacerbation after each dose. A single case of impending graft rejection was summarized as possibly related. Evaluation of immunogenicity showed that 57% of patients after CART infusion and 75% patients after allogeneic HCT had evidence of humoral and/or cellular response to the vaccine. On cox regression model, longer time from infusion of cells, female sex, and higher CD19 + cells were associated with a positive humoral response, whereas higher CD4 + /CD8 + ratiowas correlated with a positive cellular response, confirmed by ELISpot test. We conclude that BNT162b2 mRNA COVID-19 vaccine has impressive immunogenicity in patients after allogeneic HCT or CART. Adverse events were mostly mild and transient, but some significant hematologic events were observed, hence, patients should be closely monitored.

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NCT02463747.

Data regarding efficacy and toxicity of Chimeric antigen receptor T cells (CAR-T) therapy in older aged -geriatric population are insufficient. Since 2019, Tisagenlecleucel and axicabtagene-ciloleucel were commercially approved for relapsed/refractory (R/R) DLBCL. From May 2019, 47 R/R DLBCL patients, ≥70 years underwent lymphopharesis in 3 Israeli centers. Elderly (n=41, mean age 76.2 years) and young (n=41, mean age 55.4 years) patients were matched based on ECOG-PS and LDH levels. There were no differences in CD4/CD8 ratio (p=.94), %CD4naiive (p=.92), %CD8 naive (p=.44) and exhaustion markers (both HLA-DR and PD-1) between CAR-T products in both cohorts. Forty-one elderly patients (87%) received CAR-T infusion. There were no differences in the incidence of grade ≥3 cytokine-release-syndrome (p=.29), grade≥3 neurotoxicity (p=.54), and duration of hospitalization (p=.55) between elderly and younger patients. There was no difference in median D7-CAR-T cell expansion (p=.145). Response rates were similar between the 2 groups (CR-46% and PR-17% in the elderly group, p=.337). Non-relapse-mortality at 1 and 3 months was 0 in both groups. With a median follow up of 7 (range, 1.3-17.2) months, 6- and 12-months progression-free and overall survival in elderly were 39% and 32%, and 74% and 69%, respectively. EORTC QLQ-C30 questionnaires, obtained at 1 month, showed worsening of disability and cancer-related-symptoms in elderly vs younger patients. We conclude that outcomes of CAR-T cell therapy are comparable between older aged-geriatric and younger patients, indicating that age as per se should not preclude CAR-T administration. Longer rehabilitation therapy is essential to improve disabilities and long-term symptoms.