Characteristics and outcomes across select CD19-directed CAR T-cell trial of adults with B-ALL with consolidative allo-HCT
| Study . | Phase . | Co-stimulatory domain . | N . | Age in years, median (range) . | CR/CRi (%) . | Outcomes (EFS/RFS/LFS/OS) . | Allo-HCT in CR . | Outcomes post-HCT vs no HCT . |
|---|---|---|---|---|---|---|---|---|
| Maude et al., 201862 and Laetsch et al., 202336 NCT02435849 | 2 | 4-1BB | 79 | 11 (3–23) | 82 | 3-year RFS of 44% 3-year OS of 63% | 11 | HCT: 8/8 alive in CR No HCT: not reported |
| Shah et al., 202147 and Shah et al., 202233 NCT02614066 | 2 | CD28 | 55 | 40 (28–52) | 71 | 6-month RFS of 58% Median OS 25.4 months | 10 | HCT: 6/10 alive in CR No HCT: 6/29 alive in CR median DOR unchanged by allo-HCT in sensitivity analysis |
| Shah NN et al., 202163 NCT01593696 | 1 | CD28 | 50 | 14 (4–30) | 62 | Median OS of 10.5 months 6-months EFS of 38% | 21 | HCT: 12/21 alive in CR No HCT: 0/7 alive in CR |
| Park et al., 201834 NCT01044069 | 1 | CD28 | 53 | 44 (23–74) | 83 | Median OS 12.9 months Median EFS 6.1 months | 17 | HCT: 5/17 alive in CR No HCT: 9/26 alive in CR no diff in EFS/OS in MRD- CR |
| Hay et al., 201935 NCT01865617 | 1/2 | 4-1BB | 53 | 39 (20-76) | 85 | Median OS 20 months in responders Median EFS 7.6 months in responders | 18 | HCT: 11/18 alive in CR No HCT: 5/27 alive in CR allo-HCT associated with improved EFS (HR = 0.29) with MRD- CR |
| Frey et al., 202064 NCT01029366 NCT02030847 | 1/2 | 4-1BB | 35 | 34 (21–70) | 69 | Median OS 19.1 months Median EFS 5.6 months | 9 | HCT: not reported No HCT: not reported allo-HCT associated with improved EFS and nonsignificant improved OS |
| Roddie et al., 202165 NCT02935257 | 1 | 4-IBB | 20 | 42 (18–62) | 85 | 2-year OS 58% 2-year EFS 48.3% | 3 | HCT: not reported No HCT: not reported |
| Gu et al., 202066 NCT02975687 | 1 | 4-1BB | 20 | 18 (3–52) | 90 | Median OS 12.9 months Median RFS 6.9 months | 14 | HCT: 7/14 alive in CR No HCT: 0/4 alive in CR |
| Zhang et al., 202037 NCT03173417 | 1/2 | 4-1BB/CD28 | 110 | 12 (2–61) | 93 | 1-year OS 64% 1-year LFS 58% | 75 | HCT: 10/75 relapsed No HCT: 13/27 relapsed allo-HCT associated with improved OS and LFS |
| Study . | Phase . | Co-stimulatory domain . | N . | Age in years, median (range) . | CR/CRi (%) . | Outcomes (EFS/RFS/LFS/OS) . | Allo-HCT in CR . | Outcomes post-HCT vs no HCT . |
|---|---|---|---|---|---|---|---|---|
| Maude et al., 201862 and Laetsch et al., 202336 NCT02435849 | 2 | 4-1BB | 79 | 11 (3–23) | 82 | 3-year RFS of 44% 3-year OS of 63% | 11 | HCT: 8/8 alive in CR No HCT: not reported |
| Shah et al., 202147 and Shah et al., 202233 NCT02614066 | 2 | CD28 | 55 | 40 (28–52) | 71 | 6-month RFS of 58% Median OS 25.4 months | 10 | HCT: 6/10 alive in CR No HCT: 6/29 alive in CR median DOR unchanged by allo-HCT in sensitivity analysis |
| Shah NN et al., 202163 NCT01593696 | 1 | CD28 | 50 | 14 (4–30) | 62 | Median OS of 10.5 months 6-months EFS of 38% | 21 | HCT: 12/21 alive in CR No HCT: 0/7 alive in CR |
| Park et al., 201834 NCT01044069 | 1 | CD28 | 53 | 44 (23–74) | 83 | Median OS 12.9 months Median EFS 6.1 months | 17 | HCT: 5/17 alive in CR No HCT: 9/26 alive in CR no diff in EFS/OS in MRD- CR |
| Hay et al., 201935 NCT01865617 | 1/2 | 4-1BB | 53 | 39 (20-76) | 85 | Median OS 20 months in responders Median EFS 7.6 months in responders | 18 | HCT: 11/18 alive in CR No HCT: 5/27 alive in CR allo-HCT associated with improved EFS (HR = 0.29) with MRD- CR |
| Frey et al., 202064 NCT01029366 NCT02030847 | 1/2 | 4-1BB | 35 | 34 (21–70) | 69 | Median OS 19.1 months Median EFS 5.6 months | 9 | HCT: not reported No HCT: not reported allo-HCT associated with improved EFS and nonsignificant improved OS |
| Roddie et al., 202165 NCT02935257 | 1 | 4-IBB | 20 | 42 (18–62) | 85 | 2-year OS 58% 2-year EFS 48.3% | 3 | HCT: not reported No HCT: not reported |
| Gu et al., 202066 NCT02975687 | 1 | 4-1BB | 20 | 18 (3–52) | 90 | Median OS 12.9 months Median RFS 6.9 months | 14 | HCT: 7/14 alive in CR No HCT: 0/4 alive in CR |
| Zhang et al., 202037 NCT03173417 | 1/2 | 4-1BB/CD28 | 110 | 12 (2–61) | 93 | 1-year OS 64% 1-year LFS 58% | 75 | HCT: 10/75 relapsed No HCT: 13/27 relapsed allo-HCT associated with improved OS and LFS |