Table 4 Summary of primary CD19 CAR-T products in R/R DLBCLs
Lines | Study | CAR-T cells | Patients | Outcomes | Toxicities of CAR T |
|---|---|---|---|---|---|
 ≥ 3 | ZUMA-1 NCT02348216 | Axi-cel | DLBCL, PMBCL, tFL, HGBCL | ORR/CRR, 83%/58% Median DOR, 11.1 mo Median OS, 25.8 mo Median PFS, 5.9 mo | ≥ Grade 3 CRS 11% ≥ Grade 3 NEs 32% |
 ≥ 3 | JULIET NCT02445248 | Tisa-cel | DLBCL, tFL, HGBCL | ORR/CRR, 53·0%/39% Median DOR, NR Median OS, 11.1 mo Median PFS, 2.9 mo | ≥ Grade 3 CRS 11% ≥ Grade 3 NEs 32% |
 ≥ 3 | TRANSCEND NHL 001 NCT02631044 | Liso-cel | DLBCL, FL3B, PMBCL, tFL; DLBCL transformed from iNHL, HGBCL | ORR/CRR, 73%/53% Median DOR, NR Median OS: 21.1 mo Median PFS: 6.8 mo | ≥ Grade 3 CRS 2% ≥ Grade 3 NEs 10% |
 ≥ 2 | ZUMA-7 NCT03391466 | Axi-cel vs. SOC | DLBCL, tFL, HGBCL with or without MYC and BCL2 and/or BCL6 rearrangement, THRBCL | ORR, 83% vs. 50% CRR, 65% vs. 32% Median EFS, 8.3 vs. 2 mo Median PFS, 14.7 vs. 3.7 mo Median OS, NR vs. 35.1 mo | ≥ Grade 3 CRS 6% ≥ Grade 3 NEs 21% |
 ≥ 2 | TRANSFORM NCT03575351 | Liso-cel vs. SOC | DLBCL, DLBCL transformed from iNHL, FL3B, HGBCL with MYC and BCL2 and/or BCL6 Rearrangement, DHL, THL, PMBCL, THRBCL | ORR, 86% vs. 48% CRR, 61% vs. 36% Median DOR, NR vs. 14.5 mo Median EFS, 10.1 vs. 2.3 mo Median PFS, 14.8 vs. 5.7 mo Median OS, NR vs. 16.4 mo | ≥ Grade 3 CRS 1% ≥ Grade 3 NEs 4% |
 ≥ 2 | BELINDA NCT03570892 | Tisa-cel vs. SOC | DLBCL, HGBCL, FL3B, transformed from previous lymphoma | ORR, 46.3% vs. 42.5% CRR, 28.4 vs. 27.5% Median EFS, 3 mo for both Median OS, 16.9 vs. 15.3 mo | ≥ Grade 3 CRS 5.2% ≥ Grade 3 NEs 1.9% |
 ≥ 2 | PILOT-017006 NCT03483103 | Liso-cel (JCAR017)) | R/R DLBCL ineligible of auto-SCT | ORR/CRR, 80%/54% Median DOR, 12.09 mo Median PFS, 9.3 mo Median EFS, 7.23 mo Median OS, NR | ≥ Grade 3 CRS 1.6% ≥ Grade 3 NEs 4.9% |