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تعداد آیتم قابل مشاهده باقیمانده: 4

Rates of immune effector cell-associated neurotoxicity syndrome (ICANS) in pivotal CAR-T cell therapy trials

Rates of immune effector cell-associated neurotoxicity syndrome (ICANS) in pivotal CAR-T cell therapy trials
Drug Disease Trial Any-grade neurotoxicity (%)* Grade ≥3 neurotoxicity (%) Steroids mandated for NT in trial protocol?
Axicabtagene ciloleucel[1,2] DLBCL ZUMA-1 64 28 Yes
FL ZUMA-5 77 11 Yes
Brexucabtagene autoleucel[3] MCL ZUMA-2 63 31 Yes
Ciltacabtagene autoleucel[4] MM CARTITUDE-1 17 2 Yes
Idecabtagene vicleucel[5] MM KarMMa 18 3 Yes
Lisocabtagene maraleucel[6] DLBCL TRANSEND NHL 001 30 10 Yes
Obecabtagene autoleucel[7] B-ALL FELIX 23 7 Yes
Tisagenlecleucel[8,9] DLBCL JULIET 21 12 No
B-ALL ELIANA 40 13 No

ASTCT: American Society for Transplantation and Cellular Therapy; B-ALL: B cell acute lymphoblastic leukemia; CAR-T: chimeric antigen receptor T; CTCAE: Common Terminology Criteria for Adverse Events; DLBCL: diffuse large B cell lymphoma; FL: follicular lymphoma; MCL: mantle cell lymphoma; MM: multiple myeloma; NT: neurotoxicity.

* Using CTCAE 4.03 grading system for neurotoxicity for all products except ciltacabtagene autoleucel, which used CTCAE 5.0 in phase 1b and ASTCT ICANS criteria in phase 2.

References:
  1. Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med 2017; 377:2531.
  2. Yescarta (axicabtagene ciloleucel) suspension for intravenous infusion. US Food and Drug Administration (FDA) product information. Revised March 2021. US National Library of Medicine. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=9b70606e-b99c-4272-a0f1-b5523cce0c59&type=display (Accessed on April 5, 2021).
  3. Wang ML, Munoz J, Goy A, et al. KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T cell therapy, in patients (Pts) with relapsed/refractory (R/R) mantle cell lymphoma (MCL): Results of the phase 2 ZUMA-2 study. Blood 2019; 134:754.
  4. Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): A phase 1b/2 open-label study. Lancet 2021; 398:314.
  5. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med 2021; 384:705.
  6. Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): A multicenter seamless design study. Lancet 2020; 396:839.
  7. Roddie C, Sandhu KS, Tholouli E, et al. Obecabtagene autoleucel in adults with B-cell acute lymphoblastic leukemia. N Engl J Med 2024; 391:2219.
  8. Schuster SJ, Bishop MR, Tam CS, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med 2019; 380:45.
  9. Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med 2018; 378:439.
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