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. Author manuscript; available in PMC: 2021 Jun 1.
Published in final edited form as: Expert Opin Biol Ther. 2020 Feb 24;20(6):653–664. doi: 10.1080/14712598.2020.1729735

Table 1:

Cytokine release syndrome, neurotoxicity and response rates in selected CD19 CAR-T cell trials.

Cell product Malignancy Study Population Costim-ulatory Domain Lymphodepletion Cell dose CRS grading system CRS Total/ severea NT grading system NT Total/ severeb Best ORR/CR
Tisagenlecleucel ALL Maude, et al [6] 75 pediatric/ young adult patients 4-1BB Flu/Cy in 71 patients and cytarabine/etoposide in 1 patientc 0.2–5.4 x 106/kg PENN grading [26] 77%/47% CTCAE 4.03[47] 40%/13% N/A/81% d
Tisagenlecleucel NHL Schuster, et al [7] 111 adult patients 4-1BB Flu 25mg/m2/day and Cy 250mg/m2/day x 3 days
or
Bendamustine 90mg/m2/day x 2 days
0.1–6 x 108 PENN grading 58%/22% CTCAE 4.03 21%/12% 52%e/40%
Axicabtagene ciloleucel NHL Neelapu, et al [2] 101 adult patients CD28 Flu 30mg/m2/day and Cy 500mg/m2/day x 3 days 2 x 106/kg Lee, et al [25] 93%/13% CTCAE 4.03 64%/28% 82%f/54%
Lisocabtagene maraleucel NHL Abramson, et al [48,61] 91 adult patients 4-1BB Flu 30mg/m2/day and Cy 300mg/m2/day x 3 days 0.5–1 x 108
(1:1 ratio of CD4:CD8 CAR-T cells)
Lee, et al 35%/1% CTCAE 4.03 19%/12% 74%e/52%

ALL - acute lymphoblastic leukemia

CRS - cytokine release syndrome

CTCAE - Common Terminology Criteria for Adverse Events

CR - complete response

Cy - cyclophosphamide

Flu - fludarabine

NT - neurotoxicity

ORR - overall response rate

NHL - non-Hodgkin's lymphoma

a

severe is grade 3 or higher, grading systems differ

b

CTCAE 4.03 grading criteria, severe is grade 3 or higher [47]

c

doses and duration not specified

d

minimal residual disease negative by flow cytometry with and without complete hematologic recovery

e

Lugano classification [59]

f

International Working Group Response Criteria for Malignant Lymphoma [60]