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CARVYKTI®

(ciltacabtagene autoleucel)

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CARVYKTI® (ciltacabtagene autoleucel)
Medical Information

CARVYKTI - Adverse Event - Infections

Last Updated: 03/02/2026

SUMMARY

  • Johnson & Johnson does not recommend the use of CARVYKTI in a manner that is inconsistent with the approved labeling.
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • Infections have been reported as an adverse event (AE) in the CARTITUDE-1, CARTITUDE-2 and CARTITUDE-4 studies.1-9
  • 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-cluster of differentiation (CD) 38 monoclonal antibody (mAb).1,2,5
    • In the CARTITUDE-1 study, administration of CARVYKTI may have increased the risk of infection due to cytopenias or hypogammaglobulinemia. Prolonged neutropenia may have increased the risk of infection.10
    • At a median follow-up of 12.4 months, infections occurred in 58% of patients (n=56) with grade 3/4 infections observed in 20% of patients (n=19).2 At a longer median follow-up of 27.7 months, treatment-emergent adverse events (TEAEs) reported were consistent with the 12.4 month median follow-up.1 Infections were not reported at the 33.4 month follow-up. Overall, fatal infections related to CARVYKTI treatment occurred in 3 patients; lung abscess (n=1), sepsis and/or septic shock (n=2).5
    • In the overall population (N=97), at 61.3-month follow-up, grade ≥3 infections were reported in 9 patients.11
    • The safety profile of CARVYKTI remained consistent with previously reported safety outcomes.1,2,5,12 
      • Among the 32 patients with ≥5 years of progression-free survival (PFS), 4 new grade ≥3 infections were reported.
  • CARTITUDE-2 is a phase 2, open-label, multicohort, single-arm, multicenter study evaluating CARVYKTI in patients with multiple myeloma (MM) in various clinical settings.13
    • Cohort A evaluates patients with RRMM who received 1-3 prior LOTs and are refractory to lenalidomide.3,7,14-16
      • Initial Subgroup: evaluated the efficacy and safety of CARVYKTI manufactured with the clinical trial process in 20 patients.3,14-16
        • At a median follow-up of 17.1 months, 2 infection related deaths were reported due to coronavirus disease 2019 (COVID-19) (n=1; treatment related; day 100) and sepsis (n=1; not treatment related; day 394).3
      • Expansion Subgroup: evaluated the efficacy and safety of CARVYKTI manufactured with a commercial process in 23 patients.7
        • At a median follow-up of 15.6 months, any-grade infections occurred in 34.8% of patients (n=8), with grade 3/4 infections reported in 4.3% of patients (n=1). A treatment-related death was reported in 1 patient due to sepsis that was diagnosed on day 30.7
    • Cohort B evaluates patients with early relapse (≤12 months after frontline therapy or ≤12 months after autologous stem cell transplant [ASCT]).15,17
      • At a median follow‑up of 10.6 months, infections were not reported.17 
      • At a median follow‑up of 27.9 months, infections were not reported.15 
    • Cohort C evaluates patients with RRMM with prior exposure to a PI, immunomodulatory drug, and an anti-CD38 mAb, and a B-cell maturation antigen (BCMA) bispecific antibody (BsAb) or antibody-drug conjugate (ADC).4,18
      • At a median follow-up of 18 months, 3 infection related deaths were reported due to COVID-19 pneumonia (n=2; 1 patient in each of the ADC-exposed and BsAb-exposed groups; not treatment related) and Clostridium difficile colitis (n=1 patient in the BsAb-exposed group; treatment related).4,18
    • Cohort D evaluates patients with RRMM who achieved less than a complete response (<CR) after frontline ASCT, with or without lenalidomide maintenance 8,19
      • At a median follow-up of 22.4 months, any-grade infections occurred in 70.6% of patients (n=12), with grade 3/4 infections observed in 29.4% of patients (n=5).8
      • At a median follow-up of 40.2 months, infections were not reported.20 
  • CARTITUDE-4 is a phase 3, open-label, multicenter study evaluating CARVYKTI versus standard care regimens, DARZALEX FASPRO (daratumumab and hyaluronidase), pomalidomide, and dexamethasone (DPd) or pomalidomide, bortezomib, and dexamethasone (PVd), in patients with RRMM who received 1-3 prior LOTs, including a PI and an immunomodulatory drug, and are refractory to lenalidomide.6,21 
    • AEs were evaluated in the safety population which included all patients who received any part of study treatment (n=208 in both the CARVYKTI and standard-care arm).6
      • At a median follow-up of 15.9 months, infections occurred in 62.0% of patients in the CARVYKTI arm (n=129) and in 71.2% of patients in the standard-care arm (n=148).6 Infection related deaths were reported in 9 patients in the CARVYKTI arm (COVID-19 pneumonia: n=7; neutropenic sepsis: n=1 and pneumonia: n=1) and in 4 patients in the standard-care arm (COVID-19 pneumonia: n=1; progressive multifocal leukoencephalopathy: n=1; respiratory tract infection: n=1 and septic shock: n=1).9
      • At a median follow-up of 21.5 months, treatment-emergent (TE) infections of any grade were reported in 61.5% and 75.5% of patients in the CARVYKTI arm (n=128) and standard-care arm (n=157), respectively. Grade ≥3 TE infections were reported in 27.4% and 26.9% of patients in the CARVYKTI arm (n=57) and standard-care arm (n=56). Grade ≥3 events decreased substantially in the CARVYKTI arm after month 6, with a more gradual decrease over time observed in the standard‑care arm.22
      • At a median follow-up of 33.6 months (interquartile range [IQR], 20.3-35.0), grade 3 TE infections occurred in 24% vs 26% of patients, and grade 4 TE infections occurred in <1% vs 1% in the CARVYKTI arm vs the standard‑care arm. Deaths due to TE and non-TE infections were reported in 16 (8%) patients in the CARVYKTI arm and 19 (9%) patients in the standard-care arm.21 

PRODUCT LABELING

clinical data - Cartitude-1 - phase 1b/2 study

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 LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.1,2,5

Study Design/Methods

  • Treatment arm: CARVYKTI (single arm)
  • Key eligibility criteria:
    • Progressive MM per International Myeloma Working Group criteria
    • ≥3 prior LOTs or double refractory to a PI and an immunomodulatory drug
    • Prior exposure to a PI, an immunomodulatory drug, and an anti-CD38 mAb
    • No prior exposure to chimeric antigen receptor (CAR)-T cell or BCMA targeting therapy
  • Primary endpoints: Recommended phase 2 dose, overall response rate

Safety - Adverse Event - Infections  

  • At a median follow-up of 12.4 months, infections occurred in 58% of patients (n=56) with grade 3/4 infections observed in 20% of patients (n=19). Upper respiratory tract infection was reported in 16% of patients (n=15); 1 patient had a grade 3 event.2
  • At a longer median follow-up of 27.7 months, TEAEs reported were consistent with the 12.4-month median follow-up. The most common grade 3/4 infections reported were pneumonia (10.3%) and sepsis (4%; n=4).1,2
  • At a median follow-up of 33.4 months (range, 1.5-45.2), infections were not reported.5
  • Fatal infections that occurred during the study are presented in Table: CARTITUDE-1: Infection Related Deaths.
    • Fatal infections related to CARVYKTI treatment occurred in 3 patients; lung abscess (n=1), sepsis and/or septic shock (n=2).5

CARTITUDE-1: Infection Related Deaths5
Deaths, n
Total (N=97)
Time of Death Post CARVYKTI Infusion (Days)
Total deaths during the study
35
45-980
AEs unrelated to treatment (n=4)
     Pneumonia
2
109, 887
     Septic shock and/or sepsis
2
917, 945
AEs related to treatment (n=3)
     Sepsis and/or septic shock
2
45, 162
     Lung abscess
1
119
Abbreviations: AE, adverse event.

Long-Term (≥5 year) Results from the CARTITUDE-1 Study

  • In the overall population (N=97), at 61.3-month follow-up, 9 patients had grade ≥3 infections.11
  • The safety profile of CARVYKTI remained consistent with previously reported safety outcomes.1,2,5,121,2,5
    • Among the 32 patients with ≥5 years of PFS, 4 new grade ≥3 infections were reported.
  • Among the 47 total deaths in CARVYKTI-treated patients overall, 17 occurred without progressive disease. Of these11:
    • 4 of 7 deaths within 12 months were due to infections.
    • 3 of 6 deaths between 24-36 months were due to infections.
    • 1 of 2 deaths between 36-60 months was due to infection.

clinical data - cartitude-2 - phase 2 study

CARTITUDE-2 (NCT04133636) is an ongoing, phase 2, open-label, multicohort, single-arm, multicenter study evaluating the efficacy and safety of CARVYKTI in patients with MM in various clinical settings.13

Study Design/Methods

  • Treatment arm: CARVYKTI (single arm)
  • Key eligibility criteria:
    • No prior CAR-T cell therapy (Cohorts A-D) or BCMA-targeted therapy
      (Cohorts A, B, D)
    • Cohort A: 1-3 prior LOTs, including a PI and an immunomodulatory drug; lenalidomide refractory.13
    • Cohort B: 1 prior LOT, including a PI and an immunomodulatory drug; disease progression ≤12 months after ASCT or ≤12 months from other antimyeloma therapy.
    • Cohort C: Previously treated with a PI, an immunomodulatory drug, an anti-CD38 mAb, and BCMA BsAb or ADC.4,13
    • Cohort D: History of 4-8 cycles of initial therapy, including induction, high-dose chemotherapy, and ASCT with or without consolidation, in patients with <CR after frontline ASCT.8,13,19
  • Primary endpoint: minimal residual disease negativity at the 10-5 sensitivity level as assessed by next-generation sequencing.3,8,13,18,19

Safety - Adverse Event - Infections - Cohort A

  • Initial Subgroup: At a median follow-up of 17.1 months (range, 3.3-23.1), deaths related to infection were: COVID-19 (n=1; treatment related; day 100) and sepsis (n=1; not treatment related; day 394).3
  • Expansion Subgroup: At a median follow-up of 15.6 months (range, 1.0-29.2), any-grade infections occurred in 34.8% of patients (n=8), with grade 3/4 infections observed in 4.3% of patients (n=1). A treatment-related death was reported in 1 patient due to sepsis that was diagnosed on day 30.7

Safety - Adverse Event - Infections - Cohort B

  • At a median follow‑up of 10.6 months (range, 4.1-17.4), infections were not reported.17
  • At a median follow‑up of 27.9 months (range, 5.2-32.1), infections were not reported.15

Safety - Adverse Event - Infections - Cohort C

  • At a median follow-up of 18 months (range, 0.6-22.7), deaths related to infection were: COVID-19 pneumonia (n=2; 1 patient in each of the ADC-exposed and the BsAb-exposed groups; not treatment related) and Clostridium difficile colitis n=1 patient in the BsAb-exposed group; treatment related).4,18

Safety - Adverse Event - Infections - Cohort D

  • At a median follow-up of 22.4 months (range, 4.7-39.3), any-grade infections occurred in 70.6% of patients (n=12), with grade 3/4 infections observed in 29.4% of patients (n=5; without lenalidomide maintenance, 20% [n=1]; with lenalidomide treatment, 33.3% [n=4]).8
  • At a median follow-up of 40.2 months (range, 4.7-55.9), infections were not reported.20

clinical data - cartitude-4 - phase 3 study

CARTITUDE-4 (NCT04181827) is a phase 3, randomized, open-label study evaluating the efficacy and safety of CARVYKTI versus standard care (physician's choice of DPd or PVd) in adult patients with lenalidomide-refractory MM after 1-3 prior LOTs.6,9,21

Study Design/Methods

  • Treatment arms: Randomized 1:1 to receive either CARVYKTI or standard care (DPd or PVd)
  • Key eligibility criteria
    • Received 1-3 prior LOTs including a PI and an immunomodulatory drug
    • Refractory to lenalidomide
    • No prior exposure to CAR-T cell or BCMA targeting therapy
  • Primary endpoint: PFS

Safety - Adverse Event - Infections

  • AEs were evaluated in the safety population which included all patients who received any part of study treatment (n=208 in both the CARVYKTI and standard-care arm).6
Median Follow-up of 15.9 Months
  • At the data cut-off date of November 1, 2022, 143 patients in the CARVYKTI arm were in the post-treatment phase and 77 patients were undergoing standard-care therapy.9
  • At a median follow-up of 15.9 months (range, 0.1-27.3), all grade infections occurred in 62.0% of patients in the CARVYKTI arm (n=129) and in 71.2% of patients in the standard-care arm (n=148) with grade 3/4 infections occurring in 26.9% of patients in the CARVYKTI arm and in 24.5% of patients in the standard-care arm.6
    • All grade COVID-19 infections were reported in 13.9% (n=29) in the CARVYKTI arm and 26.4% (n=55) in the standard-care arm.
      • Grade 3/4 COVID-19 occurred in 2.9% (n=6) in the CARVYKTI arm and 5.8% (n=12) in the standard-care arm.
    • All grade upper respiratory tract infections were reported in 18.8% (n=39) in the CARVYKTI arm and 26% (n=54) in the standard-care arm.
      • Grade 3/4 upper respiratory tract infections occurred in 1.9% (n=4) in the CARVYKTI arm and 1.9% (n=4) in the standard-care arm.
    • All grade lower respiratory tract/lung infections were reported in 9.1% (n=19) in the CARVYKTI arm and 17.3% (n=36) in the standard-care arm.
      • Grade 3/4 lower respiratory tract infections occurred in 4.3% (n=9) in the CARVYKTI arm and 3.8% (n=8) in the standard-care arm.
  • Infection related deaths were reported in 9 patients in the CARVYKTI arm (COVID-19 pneumonia: n=7; neutropenic sepsis: n=1 and pneumonia: n=1) and in 4 patients in the standard-care arm (COVID-19 pneumonia: n=1; progressive multifocal leukoencephalopathy: n=1; respiratory tract infection: n=1 and septic shock: n=1).
Median Follow-up of 21.5 Months
  • At a median follow-up of 21.5 months (range, 0.1-32.8; date cut-off date of April 2023), TE infections of any grade were reported in 61.5% of patients in the CARVYKTI arm (n=128) and 75.5% of patients in the standard-care arm (n=157). In the CARVYKTI and standard-care arms, respectively:22
    • Viral infections occurred in 29.8% and 43.3% of patients.22
    • Bacterial infections occurred in 16.8% and 10.6% of patients.22
    • Fungal infections occurred in 5.8% and 9.6% of patients and were invasive in 4 patients (grade 3/4, n=2) and 5 patients (grade 3/4, n=2), respectively.22
  • Grade ≥3 TE infections were reported in 27.4% and 26.9% of patients in the CARVYKTI arm (n=57) and standard-care arm (n=56), respectively.22
  • TE fatal infections occurred in 9 patients (4.3%) in the CARVYKTI arm and 6 patients (2.9%) in the standard-care arm, most of which occurred in the first 9 months after the study treatment start.22
    • Overall, 7 fatal infections in the CARVYKTI arm and 2 fatal infections in the standard-care arm were due to COVID-19 pneumonia; most of these occurred during the pandemic’s omicron wave.22
      • None of the patients who died of COVID-19 in the CARVYKTI arm were fully vaccinated; none of these deaths occurred after implementation of protocol-specified COVID-19 mitigation strategies.22
  • After infusion, among the 176 patients who received CARVYKTI as study treatment, 54 patients (30.7%) had grade ≥3 TE and non-TE infections, which occurred most often in the first 6 months after infusion.22
    • Fatal TE and non-TE infections occurred in 11 patients who received CARVYKTI as study treatment, including the 7 patients in the safety set who died due to COVID-19.22
  • Immune recovery in patients who received CARVYKTI as study treatment:22
    • B-cell counts in blood began to return to baseline levels approximately 4 months post infusion and reached baseline at approximately 9 months post infusion.22
    • After treatment with CARVYKTI, IgM and IgA levels returned to baseline after approximately 1 and 2 years, respectively.22
    • Starting at day 168 post infusion, the median CD4+ T cell counts began to rise above the lower limit of normal (200 x 106/µL).22

CARTITUDE-4: Patients With Grade ≥3 TE Infections (Median Follow-up of 21.5 Months)22

A graph with numbers and a bar Description automatically generated

Abbreviations: cilta-cel, ciltacabtagene autoleucel; SOC, standard-of-care; TE, treatment-emergent.

Median Follow-up of 33.6 Months
  • At the data cut-off date of May 1, 2024, 117 patients in the CARVYKTI arm were in the post-treatment phase and 43 patients were undergoing standard-care therapy.21
  • At a median follow-up of 33.6 months (IQR, 20.3-35.0), grade 3 TE infections occurred in 24% vs 26% of patients, and grade 4 TE infections occurred in <1% vs 1% in the CARVYKTI arm vs the standard‑care arm.21
  • In the safety population, grade 5 infections were reported in 16 (8%) patients in the CARVYKTI arm and 19 (9%) patients in the standard-care arm.21
    • Of these patients, 13 in the CARVYKTI arm and 8 in the standardofcare arm died during the first year, and 2 in the CARVYKTI arm and 8 in the standardofcare arm died during the second year from the start of study treatment.
  • Intravenous immunoglobulin was administered to 71% and 20% of patients in the CARVYKTI and standard-care arm, respectively.21 
  • Details of infections and infestations are provided in Table: CARTITUDE-4: Treatment-Emergent Infections and Infestations.

CARTITUDE-4 Study: Treatment-Emergent Infections and Infestations (≥5% in Any Grade)23,a
Parameter
CARVYKTI (n=208)
Standard Care (n=208)
Grade 1 or 2
Grade 3
Grade 4
Grade 5
Grade 1 or 2
Grade 3
Grade 4
Grade 5
Infections and infestations, n (%)
73 (35.1)
49 (23.6)
1 (0.5)  
9 (4.3)
96 (46.2)
54 (26.0)
2 (1.0)
7 (3.4)
   URTI
19 (9.1)
4 (1.9)
0 (0)
0 (0)
48 (23.1)
4 (1.9)
0 (0)
0 (0)
   COVID-19
17 (8.2)
3 (1.4)
0 (0)
0
57 (27.4)  
6 (2.9)
0
0
   RTI
15 (7·2)
2 (1·0)
0 (0)
0 (0)
15 (7·2)
1 (0·5)
0 (0)
1 (0·5)
   Nasopharyngitis
12 (5·8)
0 (0)
0 (0)
0 (0)
21 (10·1)
0 (0)
0 (0)
0 (0)
   UTI
8 (3·8)
3 (1·4)
0 (0)
0 (0)
12 (5·8)
3 (1·4)
0 (0)
0 (0)
   Pneumonia
6 (2.9)
8 (3.8)
0 (0)
1 (0.5)
12 (5.8)
11 (5.3)
1 (0.5)
0
   Bronchitis
4 (1·9)
0 (0)
0 (0)
0 (0)
20 (9·6)
1 (0·5)
0 (0)
0 (0)
   COVID-19
   pneumonia
2 (1.0)
3 (1.4)
0 (0)
7 (3.4)
0
12 (5.8)
0
2 (1.0)
Abbreviations: COVID‑19, coronavirus disease 2019; RTI, respiratory tract infection; TE, treatment‑emergent; URTI, upper respiratory tract infection; UTI, urinary tract infection.
aAt a median follow-up of 33.6 months (interquartile range, 20.3-35.0).

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 02 March 2026.

 

References

Show
1 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.  
2 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.  
3 Einsele H, Cohen A, Delforge M, et al. Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel, a BCMA-directed CAR-T cell therapy, in lenalidomide-refractory patients with progressive multiple myeloma after 1-3 prior lines of therapy: CARTITUDE-2, Cohort A. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2022; Chicago, IL/Virtual.  
4 Cohen A, Mateos M, Cohen Y, et al. Efficacy and safety of cilta-cel in patients with progressive MM after exposure to other BCMA-targeting agents. Blood. 2023;141(3):219-230.  
5 Lin Y, Martin G, Usmani SZ, et al. CARTITUDE-1 final results: phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma. Oral presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL/Virtual.  
6 San-Miguel J, Dhakal B, Yong K, et al. Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. N Engl J Med. 2023;389(4):335-347.  
7 Cohen A, Voorhees P, Martin T, et al. Ciltacabtagene autoleucel in patients with lenalidomide-refractory multiple myeloma: CARTITUDE-2 cohort A expansion subgroup. Poster presented at: American Society of Clinical Oncology; May 30 - June 4, 2024; Chicago, IL.  
8 Arnulf B, Kerre T, Agha M, et al. Efficacy and safety of ciltacabtagene autoleucel ± lenalidomide maintenance in newly diagnosed multiple myeloma with suboptimal response to frontline autologous stem cell transplant: CARTITUDE-2 Cohort D. Oral Presentation presented at: The American Society of Clinical Oncology (ASCO) Annual Meeting; May 31–June 4, 2024; Chicago, IL.  
9 San-Miguel J, Dhakal B, Yong K, et al. Supplement to: Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. N Engl J Med. 2023;389(4):335-347.  
10 Berdeja JG, Madduri D, Usmani SZ, et al. Supplement to: 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):1-277.  
11 Jagannath S, Martin TG, Lin Y, et al. Supplement to: Long-term (≥5-year) remission and survival after treatment with ciltacabtagene autoleucel in CARTITUDE-1 patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2025. doi:10.1200/jco-25-00760.  
12 Jagannath S, Martin T G, Lin Y, et al. Long-term (≥5-year) remission and survival after treatment with ciltacabtagene autoleucel in CARTITUDE-1 patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2025. doi:10.1200/jco-25-00760.  
13 Janssen Research & Development, LLC. A study of JNJ-68284528, a chimeric antigen receptor t cell (CAR-T) therapy directed against b-cell maturation antigen (BCMA) in participants with multiple myeloma (CARTITUDE-2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2026 March 02]. Available from: https://clinicaltrials.gov/ct2/show/NCT04133636 NLM Identifier: NCT04133636.  
14 Cohen Y, Cohen A, Delforge M, et al. Efficacy and safety of ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy, in lenalidomide-refractory patients with progressive multiple myeloma after 1-3 prior lines of therapy: updated results from CARTITUDE-2. Poster presented at: 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual.  
15 Hillengass J, Cohen AD, Agha M, et al. The phase 2 CARTITUDE-2 trial: updated efficacy and safety of ciltacabtagene autoleucel in patients with multiple myeloma and 1–3 prior lines of therapy (cohort A) and with early relapse after first line treatment (cohort B). Oral Presentation presented at: 65th American Society of Hematology (ASH) Annual Meeting and Exposition; December 9-12, 2023; San Diego, CA.  
16 Agha M, Cohen A, Madduri D, et al. CARTITUDE-2: efficacy and safety of ciltacabtagene autoleucel, a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma after 1-3 prior lines of therapy. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 4-8, 2021; Virtual.  
17 Van de Donk NCWJ, Delforge M, Agha M, et al. CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, in patients with multiple myeloma and early relapse after initial therapy. Poster presented at: 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual.  
18 Cohen A, Mateos M, Cohen Y, et al. Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to non-cellular anti-BCMA immunotherapy. Poster presented at: 64th American Society of Hematology (ASH) Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA.  
19 Einsele H, Van de Donk NCWJ, Arnulf B, et al. CARTITUDE-2 phase 2 multicohort study of ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T (CAR-T) cell therapy, in patients with multiple myeloma (MM). Poster presented at: 7th World Congress on Controversies in Multiple Myeloma (COMy); May 7-9, 2021; Virtual meeting.  
20 Cohen Y, Kerre T, Delforge M, et al. Efficacy/safety of cilta-cel ± lenalidomide maintenance in patients with multiple myeloma who had suboptimal response to frontline ASCT: updated follow-up from CARTITUDE-2 cohort D. Poster presented at: International Myeloma Society (IMS) Annual Meeting; September 17-20, 2025; Toronto, Canada.  
21 Einsele H, San-Miguel J, Dhakal B, et al. Cilta-cel in lenalidomide-refractory multiple myeloma (CARTITUDE-4): an updated analysis including overall survival from an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2026;27(2):254-268.  
22 van de Donk NWCJ, Martinez-Lopez J, Dhakal B, et al. Infections and immune reconstitution in the phase 3 CARTITUDE-4 trial of ciltacabtagene autoleucel vs standard care in patients with lenalidomide-refractory multiple myeloma and 1-3 prior lines. Poster presented at: International Myeloma Society (IMS) Annual Meeting; September 25-28, 2024; Rio de Janeiro, Brazil.  
23 Einsele H, San-Miguel J, Dhakal B, et al. Supplement to: Cilta-cel in lenalidomide-refractory multiple myeloma (CARTITUDE-4): an updated analysis including overall survival from an open-label, multicentre, randomised, phase 3 trial. [published online ahead of print January 07, 2026]. Lancet Oncol. doi:10.1016/s1470-2045(25)00653-9.