Table 1 Clinically approved CD19 CAR-T cell in B-cell lymphoma and B-ALL: Real-world Data
Clinical trials (reference) | CIBMTR Registry [29] | CIBMTR Registry [6] | Descar-T French National Registry [32] | Descar-T Registry and Lysa Group [41] | US Lymphoma CAR-T Consortium [40] | |
|---|---|---|---|---|---|---|
Study type | Non-interventional prospective | Non-interventional prospective | Retrospective | Prospective | Retrospective | Retrospective |
Indication | R/R aggressive B-NHL | R/R ALL | R/R aggressive B-cell lymphoma | R/R MCL | R/R LBCL | R/R MCL |
Follow-up (months) | 15.8 months | 21.5 | 7.9 | 3.3 | 32.4 | 3.0 |
Patients (n) | 405 | 400 | 550 | 57 | 275 | 93 |
Age (years) | 66 (54.3% of patients aged ≥ 65 years) | 13.9 (aged < 25 years) | 62 | 67 | 60 | 67 |
Prior HSCT (auto/allo) | NA | 28.8% | 48% | NA | 35.3% | 27% |
Medium number of previous lines of therapy | 3 | 3 | 3 | 3 | 3 | 3 |
Bridging therapy permitted | NA | NA | 87.8% | 87.2% | 54% | 65% |
Median turnaround time between leukapheresis and infusion (d) | 27 | 27 | 50 | 56 | NA | NA |
Response rate (ORR/CR) | ORR 59.4% CR 39.5% | CR 87.3% | NA | ORR 88% CR 61.9% | ORR 82% CR 64% | ORR 86% CR 64% |
OS | 1-year 60.3% | 1-year 79.5% | NA | NA | 1-year 68.5% 2-year 56.4% 3-year 52.2% | 6-month 82.1% |
PFS | 1-year 33.5% | 1-year 54.3% | NA | 6-month 57.9% | 1-year 47.4% 2-year 41.6% 3-year 37.3% | 3-month 80.6% |
Risk factors for response | NA | Age ≥ 18y; heavy pretreatment; disease burden | High LDH level at time of infusion; time to failure < 1 month after infusion | NA | age > 60; high LDH level at time of conditioning | NA |
Grade ≥ 3 neutropenia | NA | 22.3% | NA | NA | NA | NA |
Grade ≥ 3 thrombocytopenia | NA | 20.8% | NA | NA | NA | NA |
CRS, any grade | 47.7% | 58% | NA | 78.7% | 91% | 88% |
ICANS, any grade | 17.0% | 27.3% | NA | 48.9% | 69% | 58% |