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Table 1 Clinical outcomes after CD19 CAR T cell therapy in patients with ALL. Data is collected from clinical trials for CD19 CAR T therapy in patients with ALL, primarily showing trials’ CAR T design and their outcomes including response rate, relapse rate and so on

From: Mechanisms underlying CD19-positive ALL relapse after anti-CD19 CAR T cell therapy and associated strategies

study(reference) CAR design vector patient population conditioning regimen CAR T cell dose response,CR persistence CAR T cell persistence relapse rate B cell aplasia time CRS
Cruz CR et al. [24] FMC63-28ζ gammaretrovirus N=4, peds and adults, 18 y (9-40 y) none 1.5×107-1.2×108/m2,dose escalation CR: 75% (3/4),3 mo (2-8 mo) 8 w-12 w+ overall: 33.3% (1/3);CD19+: 33.3% (1/3) N/A none
Lee DW et al. [9] FMC63-28ζ gammaretrovirus N=20, peds and young adults, 15 y (5-27 y) FC (0.03-3)×106/kg,dose escalation CR: 70% (14/20),N/A detectable up to 68 d overall: 14.3% (2/14);CD19-: 14.3% (2/14) 14-28 d 28.6% (6/31) with Gr 3/4 CRS
Kebriaei P et al. [23] FMC63-28ζ sleeping beauty N=17, adults31 y (21-56 y) N/A 106-108/m2,dose escalation CR: 64.7% (11/17), 6 mo (2-18 mo) autologous: 201 d;allogeneic: 51 d overall: 45.5% (5/11);CD19 expression not tested N/A none
Jacoby E et al. [16] FMC63-28ζ gammaretrovirus N=20, peds and adults, 11 y (5-48 y) FC 1 × 106/kg CR: 90% (18/20), 28 d-21 mo,1-year EFS and OS rates were 73% and 90%, respectively median: 23 d overall: 22.2% (4/18);CD19+: 16.6% (3/18);CD19-: 5.6% (1/18) N/A 20% (4/20) with Gr 2/3 CRS
Park JH et al. [12] SJ25-28ζ gammaretrovirus N=53, adults, 44 y (23-74 y) Cy (1.5-3)×106/kg CR: 83% (44/45),N/A, median EFS: 6.1 mo,median OS: 12.9 mo 14 d (7 d-138 d) overall: 56.8% (25/44);CD19+: 47.7% (21/44);CD19-: 9.1% (4/44) N/A 26% (14/53) with sCRS
Tu S et al. [25] FMC63-28ζ lentivirus N=25, adults, 36 y (18-67 y) FC median dose of 7.133×105/kg CR: 88% (22/25),N/A,median DFS: 257 d,median OS: 267 d up to 11 mo in one patient overall: 31.8% (7/22);CD19+: 22.7% (5/22);CD19-: 9.1% (2/22) N/A no sCRS
Maude SL et al. [11] FMC63-BBζ lentivirus N=30, peds (n=25),11 y (5-22 y); adults (n=5),47 y (26-60 y) none/FC/Cy/CAVD/clofarabine/Cy+VP (0.76-20.6)×106/kg CR: 90% (27/30), 6 w-8.5 mo, up to 24 mo,6-month EFS: 67% at 6 months, the probability of CAR T cell persistence was 68% overall: 29.2% (7/27);CD19+: 14.8% (4/27), with early loss of CAR T cells;CD19-: 11.1% (3/27) 2-3 mo 27% (8/30) with sCRS
Hu, Y et al. [26] FMC63-BBζ lentivirus N=15, adults<60 y FC (1.1-9.8) × 106/kg,dose-escalation CR: 80% (12/15),1 mo,median LFS: 143 d up to 7 mo overall: 50% (6/12);CD19+: 16.7% (2/12);both CD19- and CD19+: 16.7% (2/12);CNS relapse: 16.7% (2/12) N/A 40% (6/15) with Gr3 CRS
Gardner RA et al. [7] FMC63-BBζ lentivirus N=43, peds and young adults, 12.3 y (1.3-25.4 y),4 of whom were <3 y 14 given FC 1×106/kg,CD4+:CD8+=1:1 CR: 93% (40/43), 12.2 mo (1.9-21.5 mo),CR=100% (14/14) in patients after FC,N/A N/A overall: 45% (18/40);CD19+: 27.5% (11/40);CD19-: 17.5% (7/40) median: 3 mo,time from loss of BCA to relapse: 3.7 mo (0-11 mo) 23% (10/40) with sCRS
Maude SL et al. [6] FMC63-BBζ lentivirus N=75, peds and young adults 72 given FC, 1 given EA (0.2-4.5)×106/kg CR: 83% (61/75), 3 mo,EFS and OS rates were 73% and 90% at 6 mo and 50% and 76% at 12 mo, respectively 168 d (20-617 d),as long as 20 mo overall: 36.1% (22/61);CD19+: 1.6% (1/61);CD19-: 24.6% (15/61) (3 with concomitant CD19+ blasts);unknown: 9.8% (6/61) probability of BCA at 6 mo after infusion was 83% 73% (55/75) with Gr 3/4 CRS
Jiang H et al. [27] FMC63-BBζ lentivirus N=53, peds and adultsrange, 10-61 y (children: 7.5%; young adults: 54.7%; adult: 37.7%) FC (0.89-4.01)×106/kg,CD4+:CD8+=1:1 CR:88.7%(47/53), 3.4mo,(1.1-15.6mo),median OS: 16.1 mo up to 18 mo overall: 44.7% (21/47);2 patients with CD19+ relapse at 10 mo and 16 mo;unknown: 40.4% (19/47) N/A 35.8% (19/53) with Gr 3/4 CRS
Hay KA et al. [28] FMC63-BBζ lentivirus N=53, adults, 39 y (20-76 y) FC/Cy 2×106/kg,CD4+: CD8+ =1:1 CR: 85% (45/53), 3.5mo(1.1-17mo),median EFS: 7.6 mo N/A overall: 48.9% (22/45); CD19+: 31.1% (14/45), 5 with diminished expression;CD19-: 13.3% (6/45);unknown: 4.5% (2/45) CD19- relapse group: ongoing;CD19+relapse: 89 d (28-184d) 19% (10/53) with CRS ≥Gr 3
Cheng Z et al. [29] FMC63-BBζ and FMC63-28ζ gammaretrovirus N=6, peds and adults, 26 y (7-45 y) FC 1 × 106/kg (mixture of 28ζ CAR T cells and BBζ CAR T cells at a 1:1 ratio) CR: 57.1% (4/7), 9 mo, (2 mo-18 mo),median OS: 12 mo N/A overall: 75% (3/4);CD19+: 50% (2/4);CD19- : 25% (1/4) N/A 66.7% (4/6) with Gr 3/4 CRS
Li S et al. [20] FMC63-BBζ and FMC63-28ζ lentivirus N=10, adults, 5 for CD19-28ζ T cells, 5 for CD19-BBζ T cells, 33 y (18-59 y) FC (0.1-9.79)×106/kg CD28 group:CR: 60% (3/5), 4, 6, 8 mo;4-1BB group:CR: 60% (3/5),2 and 8 mo, and 1 is still alive no more than 1 mo in most patients;persistence over 2 mo was observed only for a patient in the 4-1BB group CD28 group: 3/3 CD19+ relapse;4-1BB group: 2/3 CD19+ relapse 2–4 mo in 6 responders no adverse events were over Gr 2
Cao J et al. [30] humanized scFv-BBζ lentivirus N=18, peds and adults (with or without prior mCAR T cell therapy), 14 y (3-57 y) FC 1 × 106/kg CR: 77.8% (14/18), 125 d (100-205 d), OS and LFS rates at d 180 were 65.8% and 71.4%, respectively median: 60 d, up to 1 y overall: 28.6% (4/14); CD19+: 21.4% (3/14);both CD19+ and CD19-: 7.2% (1/14) median 111 d 22.2% (4/18) with CRS≥Gr 3
Zhao Y et al. [31] humanized scFv-BBζ lentivirus N=5, peds and young adults (with prior mCAR T cell therapy), 14 y (9-21 y) FC (0.3-3) × 106/kg CR: 80% (4/5),N/A 30 d-11 mo N/A 20 d-2 mo none with CRS>Gr2