Table 1.
Category | Description of criteria |
---|---|
Population |
Patients with any B cell malignancy, with no restriction to age or gender, receiving CD22-targeted CAR T cell therapy. B cell malignancies include B cell acute lymphoblastic leukemia (B-ALL), B cell non-Hodgkin lymphoma (B-NHL), and B cell chronic lymphoblastic leukemia (B-CLL). |
Intervention |
CD22 CAR T cell therapy or any combination CAR regimen that includes a CD22 targeting CAR. This includes examples such as: - Sequential infusion of CD22 CAR T cell with another CAR T cell product - Coadministration of CD22 CAR T cell with another CAR T cell product - Infusion of a CAR T cell population that co-expresses multiple CARs, one being anti-CD22 CAR - Infusion of a CAR T cell population expressing a single multivalent CAR vector that targets CD22 and other antigen(s) Only second-generation CARs and later will be included. First-generation CARs will be excluded as their limited efficacy is well-established [34]. |
Comparator(s) |
- No comparators (single-arm study) - Salvage chemotherapy - Other targeted therapies (ex. other CAR T cell therapies, antibody-based therapies) - Stem cell transplant |
Outcome(s) |
Primary outcome: - Complete response Secondary outcomes: - Overall response [35] - Minimal residual disease (in B-ALL) - Progressive disease - Relapse - Overall survival - Progression-free survival - B cell aplasia - CAR T cell expansion and persistence - Stem cell transplant post-CAR therapy - Antigen expression (CD19, CD22) on malignant cells before and after CAR T cell therapy - Adverse events (infection, neurotoxicity, cytokine release syndrome, graft-versus-host-disease; other types will be grouped by organ system affected and severity) - Manufacturing outcomes Tertiary outcomes - Health-related quality of life - Patient-reported outcomes |
Study characteristics | Interventional: ± controlled, ± randomized |