Table 2.
Grade ≥ 3 CRS and ICANS, and response rates
| Study details (Author; Indication) | N | Dose/s used (million cells)a | Dose and Fractionation regimen (% of total dose) | Grade ≥ 3 CRS and ICANS | Response Rate |
|---|---|---|---|---|---|
| Studies with single dose and fractionated-dose patients | |||||
| Frey NV(35); ALL | FD, 20; SD, 6 | 500 | 10, 30, 60 (d1,2,3) |
CRS, 5% in FD patients and 50% SD patients ICANS not reported |
CRR, 90% in FD patients and 50% in SD patients ORR not reported |
| Frey NV(37); CLL |
FD, 8; SD, 11 |
500 | 10, 30, 60 (d1,2,3) |
CRS, 25%; ICANS, 0% in FD patients CRS, 36%; ICANS, 18% in SD patients |
ORR, 50%; CRR, 38% in FD patients ORR, 55%; CRR, 36% in SD patients |
| Xu J(36); Multiple Myeloma |
FD, 8; SD, 9 |
49 (average) | 0, 3, 6d (33% each) | CRS, 63% in FD patients and 22% in SD patients |
ORR, 100%; CRR, 71% in FD patients ORR, 89%; CRR, 89% in SD patients |
| Anti CD19 CAR-T cells | |||||
| Li M(48); B-ALL | 78 | 350 | 10, 30, 60 | CRS, 29%; ICANS, not reported | ORR/CRR, 83% |
| Jiang H(22); B-ALL | 53 | 280.7 | No details (0-2d) | CRS, 36%; Grade 2/3 ICANS, 15% | ORR/CRR, 89% |
| Ying Z(28); B-cell lymphoma | 25 | DL1, 3–6; DL2 60–190; DL3, 200–400 | 30, 30, 40 (0-2d) | CRS, 0%; ICANS, 0% | ORR, 60%; CRR, 28% |
| Roddie C(40); B-ALL | 20 | 410 | 33, 67 or 2.5, 97.5 on d0, d9 | CRS, 0%; ICANS, 15% | ORR/CRR, 85% |
| Wang CM(45); Hodgkins Lymphoma | 18 | 770–1470 | starting with 21 M, increments of 5-fold (e.g. 100 M cells) over 3–5 days | CRS and ICANS, 0% | ORR, 39%; CRR, 0% |
| Geyer MB(38); CLL | 16 | 280–2100 | 33, 67 (0,1d) | CRS, 13%; ICANS, 6% | ORR/CRR, 19% |
| Davila ML(41); B-ALL | 16 | 210 | 33, 67 d1, d2 | Severe CRS, 44% and severe ICANS, 25% (not categorized as Grade 3+) | ORR/CRR, 88% |
| Sauter CS(39); B-cell Lymphoma | 15 | DL1, 350; DL2, 700 | 67, 33 (d2, d3) | CRS, 20%; ICANS, 6% | ORR/CRR, 53% |
| Hu Y(46); ALL | 15 | 77–686 | No details (0-2d) | CRS, 40%; ICANS, not reported | ORR/CRR, 73% |
| Porter DL(47); CLL | 14 | 14-1100 | 10, 30, 60 (0-2d) | CRS, 43%; ICANS, 7% | ORR, 57%; CRR, 29% |
| Geyer MB(27); CLL | 8 | 280–2100 | 33, 67 (0,1d) | CRS, 0%; ICANS, 0% | ORR/CRR, 25% |
| Zhang Q(29); B-ALL | 4 | ND | 33, 67 (2d) | CRS, 0%; ICANS, not reported | ORR, 75%; CRR, not reported |
| Kalos M(44); CLL | 3 | 140, 580 and 1100 | 10, 30, 60 (0-2d) | Not reported | ORR, 100%; CRR, 67% |
| Anti-BCMA CAR-T cells | |||||
| Zhao WH | 57 | 4.9 to 147 | 20%, 30%, 50% (0-7d) | CRS, 7%; ICANS, 0% | ORR, 88%; CRR, 68% |
| Cohen AD | 25 | 10–500 | 10, 30, 60 (0-2d) | CRS, 32%; ICANS, 12% | ORR, 48%; CRR, 8% |
*dose calculated for 70 kg if administered per kg