Table 1 Description of lymphodepletion doses and anti-CD19 CAR – T kinetics in pivotal clinical trials in lymphoma.
CAR-T product [Commercial name] | Indications [Clinical trial] | Formulation | Lymphodepletion regimen | Timing | Cellular CAR-T Kinetics | Reference | ||
|---|---|---|---|---|---|---|---|---|
Median peak | AUC0-28 | Median time to peak (days) | ||||||
Axicabtagene ciloleucel [Yescarta] | R/R DLBCL, PMBCL, HGBCL, tFL [ZUMA-1] | Anti-CD19 CD28 | Flu 30 mg/m2/d + Cy 500 mg/m2/d | Day -5 to -3 | Responders (n = 29) | NA | Neelapu SS et al, [94] | |
65.76 cells/μL | 799.69 cells/μL x days | |||||||
Relapse (n = 51) | ||||||||
35.27 cells/μL | 455.32 cells/μL x days | |||||||
Non-responders (n = 17) | ||||||||
12.08 cells/μL | 88.47 cells/μL x days | |||||||
R/R LBCL [ZUMA-7] | Anti-CD19 CD28 | Flu 30 mg/m2/d + Cy 500 mg/m2/d | Day -5 to -3 | 25.84 cells/mm³ | NA | 7 (range 2-233) | Locke FL et at, [95] | |
Tisagenlecleucela [Kymriah] | R/R DLBCL [JULIET] | Anti-CD19 4-1BB | Flu 25 mg/m2/d + Cy 250 mg/m2/d | Day -5 to -3 | FluCy (n = 85) | Andreadis C et al, [36] | ||
6310 copies/μg | 65000 (copies/μg) x days | 8.97 | ||||||
Bendamustine 90 mg/m2/d | Day -5 to -4 | Bendamustine (n = 22) | ||||||
5370 copies/μg | 53600 (copies/μg) x days | 8.82 | ||||||
R/R FL [ELARA] | Anti-CD19 4-1BB | Flu 25 mg/m2/d + Cy 250 mg/m2/d | Day -5 to -3 | Responders (CR or PR, n = 81) | Fowler NH et al, [39] | |||
6280 copies/μg | 57500 copies/μg x days | 9.92 | ||||||
Bendamustine 90 mg/m2/d | Day -5 to -4 | Non-responders (SD or PD n = 12) | ||||||
3000 copies/μg | 20100 copies/μg x days | 13 | ||||||
Lisocabtagene maraleucel [Breyanzi] | R/R DLBCL, HGBCL, PMBCL, tFL, FL grade 3B [TRANSCEND] | Anti-CD19 4-1BB | Flu 30 mg/m2/d + Cy 300 mg/m2/d | Day -5 to -3 | 23928·2 copies/μg | 213730·1 day x copies/μg | 12 (range 10-14) | Abramson JS et al, [95] |
Brexucabtagene autoleucel [Tecartus] | R/R MCL [ZUMA-2] | Anti-CD19 CD28 | Flu 30 mg/m2/d + Cy 500 mg/m2/d | Day -5 to -3 | 97.5 cells/μLb | 1386.3 cells/μL x dayb | 15 | Wang M et al, [96] |
