Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma

Safety of chimeric antigen receptor (CAR) T-cell therapy

Safety defined as blood count recovery of neutrophils and platelets to grade 2 or less within 6 weeks of CAR-T cell administration; incidence of infections; and cytokine release syndrome as defined by the 2019 American Society for Transplantation and Cellular Therapy harmonized system. The incidence of toxicity will be summarized using frequency and percentage and presented by overall and for each CD4 cohort.

Feasibility of CAR-T Therapy

Feasibility defined as ability of enrolled participants in each cohort to receive axicabtagene ciloleucel. Feasibility will be estimated as the proportion of participants who receive axicabtagene ciloleucel among all enrolled participants who undergo leukapheresis. A two-sided 95% exact confidence interval will also be reported together with the estimated proportion. Production failure will be defined as the number of episodes of "inability to collect sufficient T-cells and/or create products." It will be summarized using descriptive statistics.

Complete response rate

Will be estimated as the proportion of participants who achieve complete response as per Lugano criteria. A two-sided exact 95% confidence interval will be reported together with the estimated response rate.

Event-free survival (EFS)

EFS is defined as the time from randomization to the earliest date of disease progression per Lugano, commencement of new lymphoma therapy, or death from any cause. The event of interest includes disease progression or treatment discontinuation for any reason. Patients who do not experience an event will be censored at the last time the patient is alive without disease progression or treatment discontinuation. The distribution of event-free survival will be presented using Kaplan-Meier survival curves. The event-free survival probability together with 95% confidence interval at specific time points will be estimated using Kaplan-Meier method.

Duration of response (DOR)

DOR defined as time from when response criteria (completer response or partial response) are met to the documentation of relapse or progression. The event of interest includes relapse, progression or death from any cause. For patients who die without disease, response duration is censored at the time of death. For patients who have not progressed, response duration is censored at the last time at which progression was assessed. The analysis approach for response duration will be similar to what has been described for event-free survival.

CD4 and CD8 counts

The difference in CD4 and CD8 counts between those who achieve complete response and those who do not will be tested for statistical significance using Wilcoxon rank sum test. The analysis will be done for both CD4 count-based cohorts separately.

Relationship between immune-mediated response and clinical response and toxicity in human immundeficiency virus (HIV)-associated B-Cell Non-Hodgkin Lymphoma treated with axicabtagene ciloleucel

The difference between cytokine profiles and those who achieve complete response and those who do not as per Lugano criteria will be tested for statistical significance using Wilcoxon rank sum test. The association between cytokine profile and cytokine release syndrome status (\>= grade 3 vs \< grade 3) as well as immune effector cell-associated neurotoxicity (\>= grade 3 vs \< grade 3) will be tested for statistical significance using Wilcoxon rank sum test.

Burden of HIV integration in the final CAR T-cell product versus the pheresis product through quantitative polymerase chain reaction

Will be summarized using descriptive statistics.