Response to bridging and feasibility of CAR-T infusion
| Apheresed patients . | No bridging . | Bridging therapy . | P-value|| . | CT bridging . | |||||
|---|---|---|---|---|---|---|---|---|---|
| Steroids . | RT . | CT . | CMT . | Low dose . | High dose§ . | RBP . | |||
| N = 49 . | N = 35 . | N = 62 . | N = 213 . | N = 16 . | N = 51 . | N = 84 . | N = 77 . | ||
| Response to bridging, N (%) | |||||||||
| CR/PR | - | - | 40 (67.8) | 64 (31.4) | 5 (33.3) | <.001 | 8 (15.7) | 23 (27.4) | 33 (42.9) |
| SD/PD/death before infusion | - | - | 19 (32.2) | 140 (68.6) | 10 (66.7) | 35 (68.3) | 60 (71.4) | 43 (57.1) | |
| Unknown | - | - | 3 | 9 | 1 | 8 | 1 | 0 | |
| CR | - | - | 4 (6.8) | 19 (9.3) | 0 | <.001 | 1 (2.0) | 7 (8.3) | 11 (14.3) |
| Infused, N (%) | |||||||||
| Infused | 40 (81.6) | 29 (82.9) | 54 (87.1) | 166 (77.9) | 11 (68.8) | .39 | 42 (82.4) | 58 (69.1) | 66 (85.7) |
| Not infused | 9 (18.4) | 6 (17.1) | 8 (12.9) | 47 (22.1) | 5 (31.3) | 9 (17.7) | 26 (31.0) | 11 (14.3) | |
| PD/CNS relapse/death due to PD | 7 | 6 | 5 | 34 | 4 | 7 | 21 | 5 | |
| Death (not PD)∗ | 0 | 0 | 1 | 4 | 1 | 0 | 2 | 2 | |
| Patient fitness/AE† | 0 | 0 | 1 | 3 | 0 | 0 | 1 | 2 | |
| Manufacturing failure | 0 | 0 | 0 | 5 | 0 | 2 | 2 | 1 | |
| Other‡ | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | |
| Apheresed patients . | No bridging . | Bridging therapy . | P-value|| . | CT bridging . | |||||
|---|---|---|---|---|---|---|---|---|---|
| Steroids . | RT . | CT . | CMT . | Low dose . | High dose§ . | RBP . | |||
| N = 49 . | N = 35 . | N = 62 . | N = 213 . | N = 16 . | N = 51 . | N = 84 . | N = 77 . | ||
| Response to bridging, N (%) | |||||||||
| CR/PR | - | - | 40 (67.8) | 64 (31.4) | 5 (33.3) | <.001 | 8 (15.7) | 23 (27.4) | 33 (42.9) |
| SD/PD/death before infusion | - | - | 19 (32.2) | 140 (68.6) | 10 (66.7) | 35 (68.3) | 60 (71.4) | 43 (57.1) | |
| Unknown | - | - | 3 | 9 | 1 | 8 | 1 | 0 | |
| CR | - | - | 4 (6.8) | 19 (9.3) | 0 | <.001 | 1 (2.0) | 7 (8.3) | 11 (14.3) |
| Infused, N (%) | |||||||||
| Infused | 40 (81.6) | 29 (82.9) | 54 (87.1) | 166 (77.9) | 11 (68.8) | .39 | 42 (82.4) | 58 (69.1) | 66 (85.7) |
| Not infused | 9 (18.4) | 6 (17.1) | 8 (12.9) | 47 (22.1) | 5 (31.3) | 9 (17.7) | 26 (31.0) | 11 (14.3) | |
| PD/CNS relapse/death due to PD | 7 | 6 | 5 | 34 | 4 | 7 | 21 | 5 | |
| Death (not PD)∗ | 0 | 0 | 1 | 4 | 1 | 0 | 2 | 2 | |
| Patient fitness/AE† | 0 | 0 | 1 | 3 | 0 | 0 | 1 | 2 | |
| Manufacturing failure | 0 | 0 | 0 | 5 | 0 | 2 | 2 | 1 | |
| Other‡ | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | |
| Infused patients . | No bridging . | Bridging therapy . | P-value . | CT bridging . | |||||
|---|---|---|---|---|---|---|---|---|---|
| . | Steroids . | RT . | CT . | CMT . | Low dose . | High dose . | RBP . | ||
| N = 40 . | N = 29 . | N = 54 . | N = 166 . | N = 11 . | N = 43 . | N = 64 . | N = 70 . | ||
| Response, N (%) | |||||||||
| CR/PR | - | - | 37 (72.6) | 63 (39.9) | 4 (40.0) | <.001 | 8 (18.6) | 24 (37.5) | 35 (50.0) |
| SD/PD/death before infusion | - | - | 14 (27.5) | 95 (60.1) | 6 (60.0) | 28 (65.1) | 38 (59.4) | 35 (50.0) | |
| Unknown | 3 | 8 | 1 | 7 | 1 | 0 | |||
| CR | - | - | 2 (3.9) | 19 (12.0) | 0 | <.001 | 1 (2.4) | 7 (12.1) | 11 (16.7) |
| Time to infusion (d), median (IQR) range | 45 (37.5-49) 33 - 189 | 42 (35-47.5) 35 - 105 | 42 (36-55) 32 - 118 | 42 (37-54) 12 - 264 | 54 (48-62) 34-74 | .17 | 40 (34-48) 12-116 | 43 (39-53) 32-159 | 41.5 (37-57) 16 - 264 |
| Number delayed >8 wk | 5 (12.5) | 2 (6.9) | 13 (24.1) | 33 (19.9) | 5 (45.5) | .049 | 7 (16.7) | 9 (15.5) | 17 (25.8) |
| Delay reasons (patients could have multiple reasons) | |||||||||
| AE | 2 | 0 | 4 | 5 | 0 | 1 | 3 | 10 | |
| PD/disease requiring further bridging | 2 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | |
| Apheresis/manufacturing capacity | 1 | 1 | 3 | 0 | 0 | 1 | 1 | 1 | |
| Bridging | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 0 | |
| CMR | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | |
| COVID | 0 | 0 | 2 | 8 | 0 | 1 | 2 | 5 | |
| Patient choice | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 1 | |
| Awaiting biopsy results | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | |
| Unknown | 1 | 1 | 4 | 14 | 4 | 1 | 3 | 10 | |
| Preinfusion characteristics | |||||||||
| Low platelets (<50) | 1 (2.5) | 4 (13.8) | 1 (1.9) | 18 (10.8) | 0 | .075 | 3 (7.1) | 10 (17.2) | 5 (7.6) |
| Low lymphocytes (<0.5) | 7 (17.5) | 12 (41.4) | 26 (48.2) | 76 (46.6) | 6 (54.6) | .008 | 23 (57.5) | 20 (34.5) | 33 (50.8) |
| LDH | |||||||||
| Normal | 12 (30.8) | 9 (31/90) | 15 (30.6) | 32 (20.0) | 0 | .057 | 8 (19.1) | 8 (13.8) | 16 (24.2) |
| >ULN | 24 (61.5) | 16 (55.2) | 23 (46.9) | 85 (53.1) | 8 (80.0) | 244 (57.1) | 27 (46.6) | 24 (51.5) | |
| >2ULN | 3 (7.7) | 4 (13.8) | 11 (22.5) | 43 (26.9) | 2 (20.0) | 8 (19.1) | 19 (32.8) | 16 (24.2) | |
| Missing | 1 | 0 | 5 | 6 | 1 | 2 | 4 | 0 | |
| Infused patients . | No bridging . | Bridging therapy . | P-value . | CT bridging . | |||||
|---|---|---|---|---|---|---|---|---|---|
| . | Steroids . | RT . | CT . | CMT . | Low dose . | High dose . | RBP . | ||
| N = 40 . | N = 29 . | N = 54 . | N = 166 . | N = 11 . | N = 43 . | N = 64 . | N = 70 . | ||
| Response, N (%) | |||||||||
| CR/PR | - | - | 37 (72.6) | 63 (39.9) | 4 (40.0) | <.001 | 8 (18.6) | 24 (37.5) | 35 (50.0) |
| SD/PD/death before infusion | - | - | 14 (27.5) | 95 (60.1) | 6 (60.0) | 28 (65.1) | 38 (59.4) | 35 (50.0) | |
| Unknown | 3 | 8 | 1 | 7 | 1 | 0 | |||
| CR | - | - | 2 (3.9) | 19 (12.0) | 0 | <.001 | 1 (2.4) | 7 (12.1) | 11 (16.7) |
| Time to infusion (d), median (IQR) range | 45 (37.5-49) 33 - 189 | 42 (35-47.5) 35 - 105 | 42 (36-55) 32 - 118 | 42 (37-54) 12 - 264 | 54 (48-62) 34-74 | .17 | 40 (34-48) 12-116 | 43 (39-53) 32-159 | 41.5 (37-57) 16 - 264 |
| Number delayed >8 wk | 5 (12.5) | 2 (6.9) | 13 (24.1) | 33 (19.9) | 5 (45.5) | .049 | 7 (16.7) | 9 (15.5) | 17 (25.8) |
| Delay reasons (patients could have multiple reasons) | |||||||||
| AE | 2 | 0 | 4 | 5 | 0 | 1 | 3 | 10 | |
| PD/disease requiring further bridging | 2 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | |
| Apheresis/manufacturing capacity | 1 | 1 | 3 | 0 | 0 | 1 | 1 | 1 | |
| Bridging | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 0 | |
| CMR | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | |
| COVID | 0 | 0 | 2 | 8 | 0 | 1 | 2 | 5 | |
| Patient choice | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 1 | |
| Awaiting biopsy results | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | |
| Unknown | 1 | 1 | 4 | 14 | 4 | 1 | 3 | 10 | |
| Preinfusion characteristics | |||||||||
| Low platelets (<50) | 1 (2.5) | 4 (13.8) | 1 (1.9) | 18 (10.8) | 0 | .075 | 3 (7.1) | 10 (17.2) | 5 (7.6) |
| Low lymphocytes (<0.5) | 7 (17.5) | 12 (41.4) | 26 (48.2) | 76 (46.6) | 6 (54.6) | .008 | 23 (57.5) | 20 (34.5) | 33 (50.8) |
| LDH | |||||||||
| Normal | 12 (30.8) | 9 (31/90) | 15 (30.6) | 32 (20.0) | 0 | .057 | 8 (19.1) | 8 (13.8) | 16 (24.2) |
| >ULN | 24 (61.5) | 16 (55.2) | 23 (46.9) | 85 (53.1) | 8 (80.0) | 244 (57.1) | 27 (46.6) | 24 (51.5) | |
| >2ULN | 3 (7.7) | 4 (13.8) | 11 (22.5) | 43 (26.9) | 2 (20.0) | 8 (19.1) | 19 (32.8) | 16 (24.2) | |
| Missing | 1 | 0 | 5 | 6 | 1 | 2 | 4 | 0 | |
RT (pneumonia), CT (Covid 19, neutropenic sepsis/PCP, sepsis, sudden death/PE), CMT (neutropenic sepsis/ischemic bowel); †RT (Clinical deterioration owing to LRTI/influenza requiring intubation), CT ( clinical deterioration–perforation, inflammatory pneumonitis, MI); ‡No bridging (patient was in CMR, decided not to proceed, MDS diagnosis), RT (patient was in CMR, decided not to proceed), CT (Patient choice), §ORR/CR rate by HDT group, all apheresed patients: HDT-Ifos, 8(26.7%)/1(3.3%); HDT-Gem, 9(25.0%)/2(5.6%); HDT-other, 9(39.1%)/4(17.4%). ORR/CR rate by HDT group, all infused patients: HDT-Ifos, 7(33.3%)/1(44.8%); HDT-Gem, 8(30.8%)/2(7.7%); HDT-other, 9(60.0%)/4(26.7%).
P-values are χ2 or Fisher exact test (discreate variables) or Kruskal-Wallis (continuous) and compare all 5 groups (except response which compares RT/CT/CMT only).