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CARVYKTI®

(ciltacabtagene autoleucel)

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CARVYKTI® (ciltacabtagene autoleucel)
Medical Information

CARVYKTI - Outpatient Administration

Last Updated: 05/05/2026

SUMMARY

  • Johnson & Johnson does not recommend the use of CARVYKTI in a manner that is inconsistent with the approved labeling.
  • Outpatient administration of CARVYKTI is being explored in the CARTITUDE-2 and CARTITUDE-5 studies.1,2 
  • 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.3-6
    • Patients are assessed for suitability for outpatient administration at the time of apheresis, prior to lymphodepletion, and again prior to CARVYKTI infusion based on investigator’s discretion, patient’s willingness, institutional guidance, and sponsor’s approval.1
    • Cohort A evaluates patients with relapsed/refractory multiple myeloma (RRMM) who received 1-3 prior lines of therapy (LOTs) and are refractory to lenalidomide.4
      • One patient was treated in an outpatient setting in Cohort A.4
        • Grade 2 cytokine release syndrome (CRS) occurred 9 days after CARVYKTI infusion, with a duration of 2 days; grade 2 isolated facial paralysis occurred 29 days after CARVYKTI infusion and resolved completely within 51 days of onset after treatment with dexamethasone.4
    • Cohort B evaluates patients with early relapse (≤12 months after frontline therapy or ≤12 months after autologous stem cell transplant [ASCT]).5
      • One patient was treated in an outpatient setting in Cohort B.5
  • CARTITUDE-5 (MMY3004) is an ongoing phase 3, randomized, open label, multicenter, global study evaluating efficacy and safety of CARVYKTI as frontline therapy in patients with newly diagnosed multiple myeloma (NDMM) not intended for transplant.2
    • Patients are assessed for suitability for outpatient administration based on investigator’s discretion, patient’s willingness, institutional guidance, and sponsor’s approval.2
    • The study is currently ongoing, and results have not been published.
  • Additional studies that evaluated CARVYKTI in an outpatient setting have been identified in addition to the data summarized above.7-10
    • Select outpatient analyses have been summarized in the Clinical Data - Real-World Studies section.  
      • Waqar et al (2024)7 reported a single-center retrospective study assessing the feasibility of outpatient CARVYKTI administration in patients with RRMM within a dedicated cellular therapy program. The overall survival (OS) and progression-free survival (PFS) rates were similar across administration settings and shorter median hospitalization duration was observed in patients managed primarily in the outpatient setting.
      • Ly et al (2024)8 reported a retrospective study assessing safety and feasibility of outpatient CARVYKTI administration. Of the 11 patients who were evaluable for ≥1 response assessment, 45% of patients (n=5) showed complete response or better (≥CR). Among the 14 patients treated with outpatient CARVYKTI, CRS was reported in 86% of patients (n=12) and immune effector cell-associated neurotoxicity syndrome (ICANS) in 29% of patients (n=4), with 50% of the events being predominantly grade 1–2. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) was reported in 2 patients (grade 1 and 2).

clinical data - CARTITUDE-2 - Phase 2 Study

CARTITUDE-2 (MMY2003; 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.3-6

  • Cohort A evaluates patients with RRMM who received 1-3 prior LOT and are refractory to lenalidomide.5
  • Cohort B evaluates patients with early relapse (≤12 months after frontline therapy or ≤12 months after ASCT).6

Study Design/Methods

  • Treatment arm: CARVYKTI (single arm)
  • Key eligibility criteria:
    • No prior CAR-T cell therapy (Cohorts A-D) or B-cell maturation antigen (BCMA)-targeted therapy (Cohorts A, B, D)
    • Cohort A: 1-3 prior LOTs, including a proteasome inhibitor (PI) and an immunomodulatory drug; lenalidomide refractory11
    • Cohort B: 1 prior LOT, including a PI and an immunomodulatory drug; disease progression ≤12 months after ASCT or ≤12 months from other antimyeloma therapy11
  • Patients are assessed for suitability for outpatient administration at the time of apheresis, prior to lymphodepletion, and again prior to CARVYKTI infusion based on investigator’s discretion, patient’s willingness, institutional guidance, and sponsor’s approval.4
  • Key clinical considerations and monitoring guidelines for outpatient administration in CARTITUDE-2 are described in the Table: CARTITUDE-2 Outpatient Administration Guidelines.
  • Primary endpoint: Minimal residual disease (MRD) negativity at the 10-5 sensitivity level defined by International Myeloma Working Group (IMWG) criteria (assessed by next-generation sequencing or next-generation flow).3-6

CARTITUDE-2: Outpatient Administration Guidelines1
Key Clinical Considerations
Patient Monitoring
  • No requirement for daily packed red blood cell or platelet infusions
  • No presence of an indwelling central line
  • No fever or active infection since study enrollment
  • No grade ≥3 nonhematologic toxicities associated with lymphodepletion
  • No significant factors for bleeding in the setting of cytopenia and clinically significant tumor lysis syndrome requiring management
  • No high tumor burden defined as ≥60% plasma cell infiltration of the marrow and/or presence of extramedullary disease
  • No deterioration in neurologic status, including mental status changes (except for diphenhydramine-related confusion/somnolence that has resolved)
  • No rapidly progressing disease
  • Estimated glomerular filtration rate of ≥40 mL/min/1.73 m2
  • AST and ALT ≤3 times upper limit of normal
Day 1-4
  • Patients will be clinically evaluated post infusion for ≥6 hours prior to discharge from the outpatient facility
  • Patients are required to stay within 30 minutes of the hospital
  • Patients will receive daily follow-up calls from the hospital
  • Hospital admission is required at any time in the event of any presenting signs and symptoms of CRS and/or neurotoxicity

Days 5-14
  • Required inpatient admission
  • Option for discharge on day 10 in the absence of CRS, neurotoxicity, or other significant AEs
    • Patients will receive daily follow-up calls through day 14
Abbreviations: AE, adverse event; ALT, alanine transaminase; AST, aspartate transaminase; CRS, cytokine release syndrome.

Results

  • Cohort A: A total of 20 patients were treated in Cohort A; 1 patient was treated in an outpatient setting.4
    • Grade 2 CRS event occurred 9 days post infusion, with a duration of 2 days.4
    • Grade 2 isolated facial paralysis occurred 29 days after CARVYKTI infusion and resolved completely within 51 days of onset after treatment with dexamethasone.4
    • Response rates specific to this patient have not been published.4
  • Cohort B: A total of 19 patients were treated in Cohort B; 1 patient was treated in an outpatient setting.3
    • Response rates specific to this patient have not been published.3

clinical data - CARTITUDE-5 - Phase 3 Study

CARTITUDE-5 (MMY3004; NCT04923893) is an ongoing, phase 3, randomized, open label, multicenter, global study evaluating efficacy and safety of CARVYKTI as frontline therapy in patients with NDMM, for whom ASCT is not planned as initial therapy. In this study, the efficacy of induction treatment with bortezomib, lenalidomide, and dexamethasone (VRd) followed by single infusion of CARVYKTI will be compared with induction treatment with VRd followed by maintenance treatment with lenalidomide and dexamethasone (Rd).2

Study Design/Methods

  • Key eligibility criteria: adult patients with NDMM per IMWG criteria, measurable disease, Eastern Cooperative Oncology Group performance status ≤1; ineligible for high dose chemotherapy with ASCT due to advanced age, comorbid conditions or deferment of ASCT.2
  • Patients are assessed for suitability for outpatient administration based on investigator’s discretion, patient’s willingness, institutional guidance, and sponsor’s approval.2
  • Key clinical considerations and monitoring guidelines for outpatient administration in CARTITUDE-5 are described in the Table: CARTITUDE-5 Outpatient Administration Guidelines.
  • Primary endpoint: PFS defined by IMWG criteria, or death, whichever occurs first.2
  • Secondary endpoints: sustained MRD-negative complete response, overall MRD-negativity rate, OS, ≥CR, time to subsequent anti-myeloma therapy, and PFS on next-line therapy, incidence and severity of AEs, pharmacokinetics and pharmacodynamics, patient reported outcomes.2

CARTITUDE-5: Outpatient Administration Guidelines2
Key Clinical Considerations
Patient Monitoring
  • No requirement for daily packed red blood cell or platelet infusions
  • No presence of an indwelling central line
  • No fever or active infection since study enrollment
  • No grade ≥3 nonhematologic toxicities associated with lymphodepletion
  • No significant factors for bleeding in the setting of cytopenia and clinically significant tumor lysis syndrome requiring management
  • No high tumor burden defined as ≥60% plasma cell infiltration of the marrow and/or presence of extramedullary disease
  • No deterioration in neurologic status, including mental status changes (except for diphenhydramine-related confusion/somnolence that has resolved)
  • No rapidly progressing disease
  • Estimated glomerular filtration rate of ≥40 mL/min/1.73 m2
  • AST and ALT ≤3 times upper limit of normal
Day 1-4
  • Patients are required to stay within 30 minutes of the hospital
  • Daily follow-up calls
  • Hospital admission is required at any time in the event of any presenting signs and symptoms of CRS and/or neurotoxicity

Days 5-14
  • Required inpatient admission
  • Option for discharge on day 10 in the absence of CRS, neurotoxicity, or other significant AEs
  • Daily follow-up calls through day 14
Abbreviations: AE, adverse event; ALT, alanine transaminase; AST, aspartate transaminase; CRS, cytokine release syndrome.

Results

  • The study is currently ongoing, and results have not been published.

CLINICAL DATA - REAL-WORLD STUDIES

Outpatient CARVYKTI Administration in Patients With RRMM: Real‑World Analysis

Waqar et al (2024)7 conducted a single-center, retrospective study evaluating the outpatient administration of CARVYKTI in patients with RRMM through an established dedicated outpatient cellular therapy service, Immune Cell Therapy (ICE T), at the Moffitt Cancer Center (MCC).

Study Design/Methods

  • The study was conducted at MCC between May 2022 and May 2023, with a focus on the first 30 days after CARVYKTI infusion in patients with RRMM.7
  • Initially, patients received lymphodepleting chemotherapy as outpatient; then received CAR-T infusion and underwent monitoring as inpatient and were later discharged to the outpatient ICE T service.7
  • Thereafter, the practice was modified to provide lymphodepleting chemotherapy, CARVYKTI infusion, and monitoring in the outpatient setting. Patients were admitted as inpatient as per clinical needs.7
  • Patients were monitored and assessed for CRS and ICANS through day +30 post infusion.7

Results

  • A total of 43 patients with RRMM were included in this analysis. The inpatient group included 6 patients (14%), the scheduled outpatient to inpatient group included 10 patients (23.3%) and the outpatient group included 27 patients (62.8%).7
  • Baseline characteristics across inpatient (n=6), outpatient (n=27), and scheduled outpatienttoinpatient (n=10) groups included median age (62 years, 61 years, and 58.5 years), male sex proportion (83.3%, 44.4%, and 40% of patients), prior autologous hematopoietic cell transplantation (33.3%, 88.9%, and 90% of patients), and median number of prior LOTs of (5, 5, and 6), respectively.7

Efficacy

  • OS and PFS rates were similar across the administration types. At a median follow-up of 7.7 months (range, 2.9-14.4), the 1-year OS was 96.3% (95% confidence interval [CI], 76.5-99.5; P=0.068) and the 1-year PFS was 85.8% (95% CI, 60.6-95.5; P=0.10) for the surviving patients from the outpatient group.7

Safety

  • The median hospitalization duration for the inpatient group was 19 days (range, 9-36).7
    • Patients from the inpatient group were hospitalized for MM-related conditions (n=4), chemotherapy-related gastrointestinal toxicity (n=1), and patient preference (n=1).
  • A total of 25 patients (92.6%) from the outpatient group were admitted after CARVYKTI infusion. The median hospitalization duration was 4 days (range, 1-33).7
    • Of these, 22 patients (81.5%) were primarily hospitalized for CRS and 5 patients were hospitalized for clinical indications (arrhythmia, infection, and social reasons).
    • Three patients (11.1%) who underwent outpatient ICE T, required a second hospital admission within 30 days of CARVYKTI infusion (2 for ICANS and 1 for infection).
  • All patients from the scheduled outpatient to inpatient group were admitted on day -1 as planned with a median hospitalization duration of 11 days.7

Outpatient CARVYKTI Administration: Safety and Feasibility

Ly et al (2024)8 conducted a retrospective study on the safety and feasibility of CARVYKTI administration in an outpatient setting.

Study Design/Methods

  • The study included patients who received CARVYKTI in an outpatient setting, with a data cutoff date of October 1, 2023.8
  • CRS, ICANS, and IEC-HS were graded as per American Society for Transplantation and Cellular Therapy (ASTCT) 2019 and 2023 criteria, and responses were graded using standard criteria.8
  • Patients received outpatient lymphodepletion chemotherapy and outpatient CARVYKTI infusion; daily monitoring was conducted for 14 days in the extended hour outpatient unit.8
  • The first patient was preemptively admitted after CARVYKTI infusion to monitor CARVYKTI safety before instituting the full outpatient paradigm.8

Results

  • A total of 14 patients received CARVYKTI in an outpatient setting, of which 1 patient had nervous system involvement.8
  • Baseline characteristics of patients treated with outpatient CARVYKTI (N=14) included a median age (58.5 years), female sex proportion (36% of patients), Revised International Staging System stage I, II, and III disease (36%, 36%, and 21% of patients, respectively), a median of 9 prior LOTs, prior autologous/allogeneic transplantation in 64% of patients, and bridging therapy prior to chimeric antigen receptor T-cell therapy infusion in 72% of patients.8
  • The median follow-up was 99.5 days (range, 13-282).8

Efficacy

Response

Response Rates in Evaluable CARVYKTI-Treated Patients8
Response
CARVYKTI
(N=14)
Best responsea
   sCR/CR/VGPR, n/n (%)
7/11 (64)
   PR/MR/SD/PD, n/n (%)
4/11 (36)
   Not evaluated, n
3
Abbreviations: CR, complete response; IMWG, International Myeloma Working Group; MR, minimal response; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.
aBased on IMWG consensus criteria in evaluable patients (n=11) with ≥1 response assessment.

Safety

  • A summary of safety outcomes are presented in Table: Summary of Safety Outcomes.
  • A total of 11 patients (79%) were admitted for toxicity management, with 4 patients being admitted within 72 hours of infusion.8
  • CRS was reported in 12 patients (86%), with 50% of events being grade 1 and 2.8
    • Patients received either tocilizumab (n=10) or anakinra (n=2).
    • One patient with grade 1 CRS was managed through close outpatient monitoring; another patient with grade 1 CRS was hospitalized for 2 days but did not require any therapeutic intervention.
  • ICANS was reported in 4 patients (29%), with 50% of events being grade 1 and 2.8
    • Patients received either steroids (n=3) or anakinra (n=1).
    • Facial paralysis was reported in 1 patient on day 16, which improved with dexamethasone and anakinra but with residual jaw numbness.
    • Parkinsonism secondary to CAR-T was reported in 1 patient on day 50, which resolved with a 4-day course of dexamethasone.
  • IEC-HS was reported in 2 patients (grade 1 and 2).8
    • Anakinra was used to treat grade 1 IEC-HS, and anakinra and ruxolitinib were used to treat grade 2 IEC-HS.
  • Of the 12 patients with a ≥30-day follow-up, 67% had absolute neutrophil count >500/μl and platelet count >20,000/μl at day 30 without transfusion in the previous week. However, 2 patients remained transfusion dependent at the data cutoff date of October 1, 2023.8

Summary of Safety Outcomes8
Toxicity
CARVYKTI
(N=14)
CRS
   CRS maximum grade 1, n (%)
6 (43)
   CRS maximum grade 2, n (%)
6 (43)
Median time to onset of CRS, days (range)
6 (0-9)
Median duration of CRS, days (range)
2.5 (1-6)
ICANS
   ICANS maximum grade 1, n (%)
2 (14)
   ICANS maximum grade 2, n (%)
2 (14)
Median time to onset of ICANS, days (range)
8 (6-14)
Median duration of ICANS, days (range)
1 (1-3)
MNT, n (%)
2 (14)
Received tocilizumab, n (%)
10 (71)
Received steroids for toxicity, n (%)
5 (36)
Received anakinra for toxicity, n (%)
3 (21)
Hospitalization, n (%)
12 (86)
   Median duration of hospitalization, days (range)
6.5 (2-11)
   Median time to admission, days (range)
5 (0-9)
   ICU admission, n (%)
1 (7)
PRBC transfusion required in <30 days, n (%)
5 (36)
Platelet transfusion required in <30 days, n (%)
3 (21)
Infection <100 days,a n (%)
4 (29)
Abbreviations: CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; ICU, intensive care unit; MNT, movement and neurocognitive toxicity; PRBC, packed red blood cell.
aDetermined by a positive culture test.

Literature Search

A literature search of Ovid MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 10 March 2026.

 

References

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1 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). Abstract presented at: 7th World Congress on Controversies in Multiple Myeloma (COMy); May 7-9, 2021; Virtual meeting.  
2 Dytfeld D, Dhakal B, Agha M, et al. Bortezomib, lenalidomide, and dexamethasone (VRd) followed by ciltacabtagene autoleucel versus VRd followed by lenalidomide and dexamethasone (Rd) maintenance in patients with newly diagnosed multiple myeloma not intended for transplant: a randomized, phase 3 study (CARTITUDE-5). Poster presented at: 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual.  
3 van de Donk NWCJ, 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.  
4 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.  
5 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.  
6 van de Donk NWCJ, Agha M, Cohen A, et al. Ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in patients with multiple myeloma (MM) and early relapse after initial therapy: CARTITUDE-2 cohort B 18-month follow-up. Poster presented at: 64th American Society of Hematology (ASH) Annual Meeting; December 10-13, 2022; New Orleans, LA/Virtual.  
7 Waqar SHB, Hansen DK, Freeman CL, et al. Evaluation of outpatient administration of ciltacabtagene autoleucel in relapsed/refractory multiple myeloma: single center experience. Transplant Cell Ther. 2024;30(2):S388.  
8 Ly A, Huff CA, Gocke C, et al. Safety and feasibility of outpatient administration of ciltacabtagene autoleucel (cilta-cel). Transplant Cell Ther. 2024;30(2):S186-S187.  
9 Gregory T, Blunk B, Cox MT, et al. CARVKYTI (cilta-cel) real world outcomes across the Sarah cannon transplant cell therapy network. Transplant Cell Ther. 2024;30(2):S385-S386.  
10 Wanca M, Mercadante G, Baer B, et al. Feasibility of outpatient administration of ciltacabtagene autoleucel for the treatment of relapsed refractory multiple myeloma: the Vanderbilt experience. Transplant Cell Ther. 2026;32(2):S432-S433. Abstract 594.  
11 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 10]. Available from: https://clinicaltrials.gov/ct2/show/NCT04133636 NLM Identifier: NCT04133636.