Recommendation for reporting of CAR T-cell attributes
| Tier . | CAR T-cell attributes . |
|---|---|
| Tier 1 | Cell source: autologous or allogeneic CAR design: vector used (eg, lentivirus/retrovirus, nonviral), antigen recognition domain (eg, scFv, murine/human), hinge/transmembrane domain, signaling domain, schematic representation of CAR construct used Manufacturing methods: PBMC or immune cell subset Product characteristics: fresh or frozen Cell dose: definition (flat dose, per kg or BSA), dosed on total cells, or CAR-positive cells |
| Tier 2 | Manufacturing methods: activation method, culture medium, cytokine/other supplementation, duration of culture, manufacturing technology, genome edits Product characteristics: transduction efficiency, vector copy number |
| Tier 3 | CAR design: additional genetic modification, construct sequence to be included in the manuscript or cross-referenced (eg, prior publication, patent filing) Manufacturing methods: activation method, cell selection, cytokines used, culture methods, supplementation with pharmacologic agents Product characteristics: immunophenotype (extended), CyToF, scRNA-seq |
| Tier . | CAR T-cell attributes . |
|---|---|
| Tier 1 | Cell source: autologous or allogeneic CAR design: vector used (eg, lentivirus/retrovirus, nonviral), antigen recognition domain (eg, scFv, murine/human), hinge/transmembrane domain, signaling domain, schematic representation of CAR construct used Manufacturing methods: PBMC or immune cell subset Product characteristics: fresh or frozen Cell dose: definition (flat dose, per kg or BSA), dosed on total cells, or CAR-positive cells |
| Tier 2 | Manufacturing methods: activation method, culture medium, cytokine/other supplementation, duration of culture, manufacturing technology, genome edits Product characteristics: transduction efficiency, vector copy number |
| Tier 3 | CAR design: additional genetic modification, construct sequence to be included in the manuscript or cross-referenced (eg, prior publication, patent filing) Manufacturing methods: activation method, cell selection, cytokines used, culture methods, supplementation with pharmacologic agents Product characteristics: immunophenotype (extended), CyToF, scRNA-seq |
BSA, body surface area; CyToF, cytometry by time of flight; PBMC, peripheral blood mononuclear cell; scFv, single-chain variable fragment; scRNA-seq, single-cell RNA sequencing.