Results of selected clinical trials testing CD19-directed CAR T-cell therapies in B-ALL
| Product . | Tisa-cel pediatric (multicenter) . | JCAR017 pediatric (SC) . | CD28-CART19 pediatric (NCI) . | CD28-CART19 pediatric (MSKCC) . | CD28-CART19 adults (MSKCC) . | JCAR015 adults (ROCKET) . |
|---|---|---|---|---|---|---|
| Age, y (range) | 11 (3 to 24) | 12 (1 to 25) | 13 (5 to 27)* | 13.5 (1 to 22.5) | 44 (23 to 74) | 39 (19 to 69) |
| Centers | 25 | 1 | 1 | 2 | 1 | n.a. |
| Costimulation | 4-1BB | 4-1BB | CD28 | CD28 | CD28 | CD28 |
| Patients, no. | 79 | 43 | 53 | 24 | 53 | 38 |
| Prior allo-SCT, % | 61 | 62 | 38* | 20 | 36 | 37 |
| High tumor burden, % | 68 (≥50)† | 48.9 (>25) | 38* (≥50) | 40 (>5) | 51 (>5) | 84 (>5) |
| Lymphodepletion | Flu/Cy† | Flu/Cy; Cy | LD or HD Flu/Cy | HD and LD Cy; Flu/Cy | Flu/Cy; Cy | Flu/Cy; Cy |
| Severe CRS, % | 48 (gr3 to 4)‡ | 23 | 13.5 (gr3 to 4) | 16 (gr3 to 5) | 26 (gr3 to 5) | 21 (gr3 to 4) |
| Severe neurotoxicity, % | 13 (gr3 to 4) | 21 (gr3 to 4) | 5 (gr3) | 28 (gr3 to 4) | 42 (gr3 to 4) | 52 (gr3 to 5) |
| CR% | 82 | 93 | 61 | 75 | 83 | 52 |
| Post–allo-SCT, % | 10 | 26 | 40 | 83 | 39 | n.a. |
| EFS/LFS/RFS | Median EFS not reached† | Median EFS 12 mo | Median LFS 18.5 mo§ | n.a. | Median EFS 6.1 mo | Median RFS 4.4 mo |
| Reference | 8 11 † | 12 | 6 * 13 | 1 | 7 | 9 |
| NCT | 02435849 | 02028455 | 01593696 | 01860937 | 01044069 | 02535364 |
| Product . | Tisa-cel pediatric (multicenter) . | JCAR017 pediatric (SC) . | CD28-CART19 pediatric (NCI) . | CD28-CART19 pediatric (MSKCC) . | CD28-CART19 adults (MSKCC) . | JCAR015 adults (ROCKET) . |
|---|---|---|---|---|---|---|
| Age, y (range) | 11 (3 to 24) | 12 (1 to 25) | 13 (5 to 27)* | 13.5 (1 to 22.5) | 44 (23 to 74) | 39 (19 to 69) |
| Centers | 25 | 1 | 1 | 2 | 1 | n.a. |
| Costimulation | 4-1BB | 4-1BB | CD28 | CD28 | CD28 | CD28 |
| Patients, no. | 79 | 43 | 53 | 24 | 53 | 38 |
| Prior allo-SCT, % | 61 | 62 | 38* | 20 | 36 | 37 |
| High tumor burden, % | 68 (≥50)† | 48.9 (>25) | 38* (≥50) | 40 (>5) | 51 (>5) | 84 (>5) |
| Lymphodepletion | Flu/Cy† | Flu/Cy; Cy | LD or HD Flu/Cy | HD and LD Cy; Flu/Cy | Flu/Cy; Cy | Flu/Cy; Cy |
| Severe CRS, % | 48 (gr3 to 4)‡ | 23 | 13.5 (gr3 to 4) | 16 (gr3 to 5) | 26 (gr3 to 5) | 21 (gr3 to 4) |
| Severe neurotoxicity, % | 13 (gr3 to 4) | 21 (gr3 to 4) | 5 (gr3) | 28 (gr3 to 4) | 42 (gr3 to 4) | 52 (gr3 to 5) |
| CR% | 82 | 93 | 61 | 75 | 83 | 52 |
| Post–allo-SCT, % | 10 | 26 | 40 | 83 | 39 | n.a. |
| EFS/LFS/RFS | Median EFS not reached† | Median EFS 12 mo | Median LFS 18.5 mo§ | n.a. | Median EFS 6.1 mo | Median RFS 4.4 mo |
| Reference | 8 11 † | 12 | 6 * 13 | 1 | 7 | 9 |
| NCT | 02435849 | 02028455 | 01593696 | 01860937 | 01044069 | 02535364 |
CRS, cytokine-release syndrome; EFS, event-free survival; gr, grade; HD, high dose; LD, low dose; LFS, leukemia-free survival; n.a., not applicable; NCI, National Cancer Institute; NCT, National Clinical Trial; MSKCC, Memorial Sloan Kettering Cancer Center; RFS, relapse-free survival; SC, Seattle Children's; SCT, stem cell transplantation.
Data derived from Lee et al.12
Data derived from Maude et al.8
Penn Scale for CRS.
For MRD−.