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CARVYKTI®

(ciltacabtagene autoleucel)

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CARVYKTI® (ciltacabtagene autoleucel)

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CARVYKTI - Use of Anakinra in the Management of Cytokine Release Syndrome in CARTITUDE-1

Last Updated: 01/21/2026

Summary

  • CARTITUDE-1 is a phase 1b/2, open label, multicenter study of CARVYKTI in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy (LOTs) including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).1,2
  • Cytokine release syndrome (CRS) has been reported as an adverse event in the  CARTITUDE-1 study. Per study protocol, CRS was managed with tocilizumab or tocilizumab plus steroids; patients not responding to these treatments could be given other anticytokine therapy (eg, anakinra) at the discretion of the investigator.3
  • Institutional experiences of anakinra use in the management of CRS in patients who received CARVYKTI as part of the CARTITUDE-1 study were evaluated.1-3
  • In CARTITUDE-1, CRS occurred in 95% of patients (n=92), with grade 3/4 CRS occurring in 4% of patients and grade 5 CRS occurring in 1 patient. The median time to onset of CRS was 7 days (range, 1-12).1-3
  • Overall, 91% of patients (n=88) were administered supportive measures to treat CRS (tocilizumab, 69%; corticosteroids, 22%; anakinra, 19%).1,3
    • Patients were given anakinra when tocilizumab did not effectively manage CRS.3
      • A total of 18 patients received anakinra to treat CRS, typically within the first 48 hours of CRS onset (range, 0-6 days).3
      • Anakinra was administered as a subcutaneous injection at a dosage of 100200 mg every 8-12 hours over a median of 2.5 days (range 1-15).3
  • CRS resolved after a median of 5 days (range, 2-10) in patients who received anakinra and tocilizumab with steroids (n=14) or without steroids (n=4).3 Median duration of CRS was 4 days (range 1-14) and CRS resolved in 99% of patients (n=91).1,3
  • No new events of CRS (no changes in the incidence, time to onset, or duration) have occurred since the median 12.4-month follow-up.1

Clinical data

CARTITUDE-1 (NCT03548207) was a phase 1b/2, open-label study evaluating the efficacy and safety of CARVYKTI in patients with RRMM after ≥3 prior LOT including a PI, an immunomodulatory drug, and an anti-CD38 mAb.1,2

Institutional experiences of anakinra use in the management of CRS in patients who received CARVYKTI as part of the CARTITUDE-1 study were evaluated.3

Study Design/Methods

  • Key eligibility criteria: adult patients with progressive MM per International Myeloma Working Group (IMWG) criteria; Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1; measurable disease; received ≥3 prior lines of therapy or double refractory; prior PI, immunomodulatory drug, and anti-CD38 therapy.1,2
  • Dosing: patients received a single infusion of CARVYKTI at a target dose of 0.75×106 chimeric antigen receptor (CAR)+ T cells/kg (target range 0.5-1.0×106) 57 days after the start of lymphodepletion (cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 given daily for 3 days on days -5 to -3).1,2
  • Primary endpoints for phase 1b: evaluate the safety and confirm the recommended phase 2 dose.2
  • Primary endpoint for phase 2: evaluate the efficacy of CARVYKTI by overall response rate (ORR).2

Results

  • Overall, of the 113 patients enrolled/apheresed, 101 patients were lymphodepleted and 97 patients were treated with CARVYKTI in the combined phase 1b/2 study.2
  • Prior to lymphodepletion, a total of 12 patients discontinued participation in the study (progressive disease, n=2; withdrawal by patient, n=2; deaths, n=8). Prior to CARVYKTI infusion, 3 patients withdrew from treatment, and 1 patient died.2
  • Patients received a median of 6 prior lines of therapy, 88% of patients were tripleclass refractory, 42% of patients were penta-drug refractory, and 99% of patients were refractory to last line of therapy.2

Safety - Adverse Events - CRS

  • The incidence, timing/duration, and management of CRS are presented in Table: CARTITUDE-1: CRS.
  • Anakinra was administered in patients for whom tocilizumab did not effectively manage CRS.3 Use of anakinra per study patient with CRS event is presented in Table: CARTITUDE-1: Use of Anakinra Per Study Patient with CRS Event.
    • A total of 18 patients received anakinra for CRS, typically within the first 48 hours of CRS onset (range, 0-6 days).3
    • Anakinra was administered as a subcutaneous injection at a dosage of 100-200 mg every 8-12 hours over a median of 2.5 days (range 1-15).3
  • CRS resolved after a median of 5 days (range, 2-10) in patients who received anakinra and tocilizumab with steroids (n=14) or without steroids (n=4).3
  • One patient died due to hemophagocytic lymphohistiocytosis (HLH) considered related to study treatment.2
  • No new events of CRS (no changes in the incidence, time to onset, or duration) occurred since the 12.4-month median follow-up.2

CARTITUDE-1: CRS1-4
Total (N=97)
Patients with CRS, n (%)
   Any gradea
92 (94.8)
   Grade 3/4
4 (4.1)
   Grade 5
1 (1)
Median time to onset of CRS, days (IQR)
7 (5-8)
   CRS onset day 4 or later, n (%)
82 (89)
   CRS onset day 6 or later, n (%)
68 (74)
Median duration of CRS, days (IQR)
4 (3-6)b
CRS resolved within 14 days of onset, n (%)
91 (99)
Supportive measures, n (%)
88 (91)
   Tocilizumab
67 (69)c
   Corticosteroids
21 (22)
   Anakinra
18 (19)
   Vasopressor used
4 (4)
   Intubation/mechanical ventilation
1 (1)
   Cyclophosphamide
1 (1)
   Etanercept
1 (1)
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; HLH, hemophagocytic lymphohistiocytosis; IQR, interquartile range.
aCRS was graded using Lee et al (Blood 2014) in the phase 1b portion of the study and ASTCT in phase 2; in this combined analysis, Lee et al criteria were mapped to 2019 ASTCT criteria for patients in the phase 1b portion.
bOne patient with 97-day duration died due to CRS/HLH.
cFour patients received ≥3 doses.

CARTITUDE-1: Use of Anakinra Per Study Patient With CRS Event3
Patient
Onset of CRS, Day Post CARVYKTI Infusion
CRS Duration, Days
Maximum CRS Toxicity Gradea
Initiation of Anakinra, Day After Onset of CRS
Cumulative Anakinra Use, Days
1b
8
2
1
1
2
2
3
97
5
6
15
3
7
4
1
1
3
4
5
4
2
2
3
5
9
3
2
2
3
6
7
6
1
1
2
7
9
6
3
3
5
8
2
6
1
4
2
9
8
7
1
3
5
10b
7
6
1
2
7
11
5
10
3
2
9
12
4
5
2
4
1
13
6
10
2
3
2
14b
2
7
1
5
2
15b
6
5
2
3
4
16
6
5
2
3
1
17
7
5
2
2
1
18
5
5
2
3
1
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome.
aCRS was graded using Lee et al (Blood 2014) in the phase 1b portion of the study and ASTCT in phase 2; in this combined analysis, Lee et al criteria were mapped to 2019 ASTCT criteria for patients in the phase 1b portion.
bPatients received only anakinra and tocilizumab; all other patients received anakinra, tocilizumab, and steroids.

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 14 January 2026.

References

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1 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(10297):314-324.  
2 Martin T, Usmani SZ, Berdeja JG, et al. Ciltacabtagene autoleucel, an anti–B-cell maturation antigen chimeric antigen receptor T-cell therapy, for relapsed/refractory multiple myeloma: CARTITUDE-1 2-year follow-up. J Clin Oncol. 2022;41(6):1265-1274.  
3 Wong SW, Richard S, Lin Y, et al. Anakinra targeting cytokine release syndrome associated with chimeric antigen receptor T-cell therapies. Poster presented at: 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual.  
4 Cohen AD, Hari P, Htut M, et al. Patient expectations and perceptions of treatment in CARTITUDE-1: ​phase 1b/2 study of ciltacabtagene autoleucel in relapsed/refractory multiple myeloma. Poster presented at: 62nd American Society of Hematology (ASH) Annual Meeting & Exposition; December 5-8, 2020; Virtual.