Anti-CD19-CAR T-cell infusions, responses, and toxicities
| Patient . | Total T cells administered per kg* . | Anti-CD19-CAR–expressing T cells administered per kg† . | Malignancy response after CAR T-cell infusion (duration in mo)‡ . | Blood B-cell depletion§ . | Grade 3 or 4 toxicities possibly or probably attributable to CAR T cells . |
|---|---|---|---|---|---|
| 1 | 1 × 106 | 0.4 × 106 | SD (3) | Yes | Tumor lysis syndrome, fatigue, cardiac ventricular dysfunction, fever, tachycardia, troponin increase, anemia, neutropenia |
| 2 | 2 × 106 | 0.7 × 106 | SD (1) | NE | None |
| 3 | 4 × 106 | 2.4 × 106 | PD | NE | Pneumonitis, hypoxia, dyspnea, fever, hypophosphatemia|| |
| 4 | 4 × 106 | 2.2 × 106 | SD (11+) | NE | None |
| 5 | 1.5 × 106 | 1.0 × 106 | CR (9+) | Yes | Hypotension |
| 6 | 7 × 106 | 4.6 × 106 | SD (3) | NE | None |
| 7 | 1 × 106 | 0.7 × 106 | PD | No | None |
| 8 | 7 × 106 | 3.9 × 106 | SD (3+) | NE | None |
| 9 | 4 × 106 | 2.2 × 106 | PR (3+) | NE | None |
| 10 | 10 × 106 | 7.8 × 106 | SD (2) | Yes | Hypotension, headache |
| Patient . | Total T cells administered per kg* . | Anti-CD19-CAR–expressing T cells administered per kg† . | Malignancy response after CAR T-cell infusion (duration in mo)‡ . | Blood B-cell depletion§ . | Grade 3 or 4 toxicities possibly or probably attributable to CAR T cells . |
|---|---|---|---|---|---|
| 1 | 1 × 106 | 0.4 × 106 | SD (3) | Yes | Tumor lysis syndrome, fatigue, cardiac ventricular dysfunction, fever, tachycardia, troponin increase, anemia, neutropenia |
| 2 | 2 × 106 | 0.7 × 106 | SD (1) | NE | None |
| 3 | 4 × 106 | 2.4 × 106 | PD | NE | Pneumonitis, hypoxia, dyspnea, fever, hypophosphatemia|| |
| 4 | 4 × 106 | 2.2 × 106 | SD (11+) | NE | None |
| 5 | 1.5 × 106 | 1.0 × 106 | CR (9+) | Yes | Hypotension |
| 6 | 7 × 106 | 4.6 × 106 | SD (3) | NE | None |
| 7 | 1 × 106 | 0.7 × 106 | PD | No | None |
| 8 | 7 × 106 | 3.9 × 106 | SD (3+) | NE | None |
| 9 | 4 × 106 | 2.2 × 106 | PR (3+) | NE | None |
| 10 | 10 × 106 | 7.8 × 106 | SD (2) | Yes | Hypotension, headache |
Total T cells refers to the total number of T cells administered including CAR-expressing and CAR– T cells.
The number of anti-CD19-CAR–expressing T cells administered was determined by flow cytometry staining for the CAR as described in the “Methods” section.
(+) indicates an ongoing response.
NE indicates not evaluable because of absent B cells prior to protocol enrollment.
Patient 3 had respiratory syncytial virus detected in bronchial washings at the time of the pneumontis, so the contribution of the anti-CD19-CAR T cells to the pneumonitis is unclear.