Table 2.
Infused Cell Characteristics and Patient Outcomes
| Patient No. | Total T Cells Infused/kg* | Infused T Cells Expressing Anti-CD19 CAR† (%) | Anti-CD19 CAR-Expressing T Cells Infused/kg† | CD8:CD4 Ratio of Infused CAR-Positive T Cells | Malignancy Response at Last Follow-Up (Interval From Infusion to Last Follow-Up in Months) | Grade 3 and 4 Toxicities‡ |
|---|---|---|---|---|---|---|
| 1 | 1 × 106 | 39.7 | 0.4 × 106 | 1.7 | SD (3) | Tumor lysis syndrome, fatigue, cardiac ventricular dysfunction, fever, tachycardia, troponin increase, anemia, neutropenia |
| 2 | 2 × 106 | 36.4 | 0.7 × 106 | 1.1 | SD (1) | None |
| 3 | 4 × 106 | 60.8 | 2.4 × 106 | 1.0 | PD | Pneumonitis, hypoxia, dyspnea, fever, hypophosphatemia |
| 4 | 4 × 106 | 55.3 | 2.2 × 106 | 3.5 | SD (31+) | None |
| 5 | 1.5 × 106 | 64.5 | 1.0 × 106 | 1.2 | CR (30+) | Hypotension |
| 6 | 7 × 106 | 65.8 | 4.6 × 106 | 2.6 | SD (3) | None |
| 7 | 1 × 106 | 68.9 | 0.7 × 106 | 0.6 | PD | None |
| 8 | 7 × 106 | 55.5 | 3.9 × 106 | 0.7 | SD (24+) | None |
| 9 | 4 × 106 | 54.6 | 2.2 × 106 | 1.4 | PR (3) | None |
| 10 | 10 × 106 | 78.4 | 7.8 × 106 | 1.1 | SD (2) | Hypotension, headache |
| 11 | 5 × 106 | 62.4 | 3.1 × 106 | 5.1 | PR (18+) | Fever, anemia, thrombocytopenia, neutropenia, hypophosphatemia |
| 12 | 7 × 106 | 74.2 | 5.2 × 106 | 0.9 | MRD-negative CR (16+) | Fever, hypophosphatemia, hypokalemia, diarrhea, headache, neutropenia |
| 13 | 10 × 106 | 71.4 | 7.1 × 106 | 0.2 | SD (9) | None |
| 14 | 10 × 106 | 69.7 | 7.0 × 106 | 1.8 | MRD-negative CR (5) | Fever, sinus tachycardia, hypotension, anemia, thrombocytopenia, neutropenia |
| 15 | 10 × 106 | 68.8 | 6.9 × 106 | 1.3 | MRD-negative CR (3) | Sinus tachycardia, hypotension, hypoxia, anemia, thrombocytopenia, febrile neutropenia, left ventricular systolic dysfunction, alkaline phosphatase increased, ALT increased, AST increased, total bilirubin increased, CPK increased, hypophosphatemia, myositis, nausea, aPTT prolonged |
| 16 | 7 × 106 | 79.7 | 5.6 × 106 | 1.2 | PD | Fever, sinus tachycardia, hypotension, hypoxia, increased bilirubin, hypophosphatemia, headache, nausea |
| 17 | 10 × 106 | 81.5 | 8.2 × 106 | 0.5 | CR (6+) | Sinus tachycardia, anemia, neutropenia, AST increased, ALT increased |
| 18 | 10 × 106 | 30.8 | 3.1 × 106 | 0.6 | SD (2) | None |
| 19 | 5 × 106 | 86.3 | 4.3 × 106 | 0.3 | PD | Fever, sinus tachycardia, hypotension, bilirubin increased, thrombocytopenia, neutropenia, sinus bradycardia, pain, hypophosphatemia, death from acidosis due to progressive lymphoma, hypercalcemia from lymphoma |
| 20 | 5 × 106 | 84.8 | 4.2 × 106 | 3.1 | MRD-negative CR (3+)§ | Fever, hypotension, dyspnea, CPK increased, AST elevated, hyponatremia, hypophosphatemia, thrombocytopenia, neutropenia, aPTT prolonged, colitis (likely infectious) |
Abbreviations: aPTT, activated partial thromboplastin time; CAR, chimeric antigen receptor; CPK, creatine phosphokinase; CR, complete remission; MRD, minimal residual disease; PD, progressive disease; PR, partial remission; SD, stable disease.
*
Total T cells refers to the total number of T cells administered, which includes CAR-expressing and CAR-negative T cells.
†
The number of anti-CD19 CAR-expressing T cells administered was determined by flow cytometry staining for the CAR as described in Methods.
‡
All grade 3 and 4 toxicities during the 4 weeks after the CAR T-cell infusion are listed.
§
Patient 20 underwent a second alloHSCT 3.5 months after CAR19 T-cell infusion while in MRD-negative CR.