PURPOSE Patients with B-cell acute lymphoblastic leukemia who experience relapse after or are resistant to CD19-targeted immunotherapies have limited treatment options. Targeting CD22, an alternative B-cell antigen, represents an alternate strategy. We report outcomes on the largest patient cohort treated with CD22 chimeric antigen receptor (CAR) T cells. PATIENTS AND METHODS We conducted a single-center, phase I, 3 + 3 dose-escalation trial with a large expansion cohort that tested CD22-targeted CAR T cells for children and young adults with relapsed/refractory CD22+ malignancies. Primary objectives were to assess the safety, toxicity, and feasibility. Secondary objectives included efficacy, CD22 CAR T-cell persistence, and cytokine profiling. RESULTS Fifty-eight participants were infused; 51 (87.9%) after prior CD19-targeted therapy. Cytokine release syndrome occurred in 50 participants (86.2%) and was grade 1-2 in 45 (90%). Symptoms of neurotoxicity were minimal and transient. Hemophagocytic lymphohistiocytosis–like manifestations were seen in 19/58 (32.8%) of subjects, prompting utilization of anakinra. CD4/CD8 T-cell selection of the apheresis product improved CAR T-cell manufacturing feasibility as well as heightened inflammatory toxicities, leading to dose de-escalation. The complete remission rate was 70%. The median overall survival was 13.4 months (95% CI, 7.7 to 20.3 months). Among those who achieved a complete response, the median relapse-free survival was 6.0 months (95% CI, 4.1 to 6.5 months). Thirteen participants proceeded to stem-cell transplantation. CONCLUSION In the largest experience of CD22 CAR T-cells to our knowledge, we provide novel information on the impact of manufacturing changes on clinical outcomes and report on unique CD22 CAR T-cell toxicities and toxicity mitigation strategies. The remission induction rate supports further development of CD22 CAR T cells as a therapeutic option in patients resistant to CD19-targeted immunotherapy.
BackgroundTobacco public education campaigns focus increasingly on hard-to-reach populations at higher risk for smoking, prompting campaign creators and evaluators to develop strategies to reach hard-to-reach populations in virtual and physical spaces where they spend time.ObjectiveThe aim of this study was to describe two novel recruitment strategies (in-person intercept interviews in lesbian, gay, bisexual, and transgender [LGBT] social venues and targeted social media ads) and compares characteristics of participants recruited via these strategies for the US Food and Drug Administration’s This Free Life campaign evaluation targeting LGBT young adults who smoke cigarettes occasionally.MethodsWe recruited LGBT adults aged 18-24 years in the United States via Facebook and Instagram ads (N=1709, mean age 20.94, SD 1.94) or intercept in LGBT social venues (N=2348, mean age 21.98, SD 1.69) for the baseline evaluation survey. Covariates related to recruitment strategy were age; race or ethnicity; LGBT identity; education; pride event attendance; and alcohol, cigarette, and social media use.ResultsLesbian or gay women (adjusted odds ratio, AOR 1.88, 95% CI 1.54-2.29, P<.001), bisexual men and women (AOR 1.46, 95% CI 1.17-1.82, P=.001), gender minorities (AOR 1.68, 95% CI 1.26-2.25, P<.001), and other sexual minorities (AOR 2.48, 95% CI 1.62-3.80, P<.001) were more likely than gay men to be recruited via social media (than intercept). Hispanic (AOR 0.73, 95% CI 0.61-0.89, P=.001) and other or multiracial, non-Hispanic participants (AOR 0.70, 95% CI 0.54-0.90, P=.006) were less likely than white, non-Hispanic participants to be recruited via social media. As age increased, odds of recruitment via social media decreased (AOR 0.76, 95% CI 0.72-0.80, P<.001). Participants with some college education (AOR 1.27, 95% CI 1.03-1.56, P=.03) were more likely than those with a college degree to be recruited via social media. Participants reporting past 30-day alcohol use were less likely to be recruited via social media (AOR 0.33, 95% CI 0.24-0.44, P<.001). Participants who reported past-year pride event attendance were more likely to be recruited via social media (AOR 1.31, 95% CI 1.06-1.64, P=.02), as well as those who used Facebook at least once daily (AOR 1.43, 95% CI 1.14-1.80, P=.002). Participants who reported using Instagram at least once daily were less likely to be recruited via social media (AOR 0.73, 95% CI 0.62-0.86, P<.001). Social media recruitment was faster (incidence rate ratio, IRR=3.31, 95% CI 3.11-3.52, P<.001) and less expensive (2.2% of combined social media and intercept recruitment cost) but had greater data quality issues—a larger percentage of social media respondents were lost because of duplicate and low-quality responses (374/4446, 8.41%) compared with intercept respondents lost to interviewer misrepresentation (15/4446, 0.34%; P<.001).ConclusionsSocial media combined with intercept provided access to important LGBT subpopulations (eg, gender and other sexual minorities) and a more diverse sample. Soc...
BackgroundYouth and young adults frequently use social media and are susceptible to tobacco use. This study is the first to provide a systematic overview of how leading tobacco product brands use popular social media platforms.MethodsWe identified 112 leading brands of e-cigarettes, hookah, cigars, cigarettes and smokeless tobacco based on sales and self-report user data. We searched for each brand on six platforms: Instagram, Facebook, Twitter, YouTube, Pinterest and Tumblr. In early 2019, we conducted a content analysis of each page, coding: age restrictions, warning display, page characteristics and post characteristics.ResultsCigarette brands were generally not present. Most e-cigarettes, hookah and cigar brands had pages on at least two platforms. One-third of smokeless brands had pages on at least one platform. Few brands had pages on Pinterest and Tumblr. Most pages had existed for 3–5 years. Overall, brand pages rarely used age gating, did not display health warnings, generally posted images of a product alone and often used hashtags unrelated to tobacco. Brands commonly used special features like ephemeral posts on Instagram and pop-up chat windows on Facebook. Many pages displayed images of young people and mentioned flavour. Median followers per brand ranged from about 1 000–10 000, and total followers summed across brands reached over 5 million on Facebook and Instagram alone.ConclusionsLeading brands of most tobacco product types use social media extensively. Several findings identify issues related to youth exposure to and appeal of tobacco social media marketing. Findings can inform tobacco education efforts and regulation.
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