Table 1 Population, intervention, comparators, outcomes, and study characteristic eligibility 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