Carvykti (ciltacabtagene autoleucel)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Ciltacabtagene autoleucel wherever you encounter it, plus the key facts at a glance.
- Generic name
- Ciltacabtagene autoleucel
- Brand name
- Carvykti
- Development code
- JNJ-68284528
- Drug class
- BCMA-directed CAR T cell therapy
- Manufacturer
- Janssen Biotech (Johnson & Johnson); co-marketed with Legend Biotech
- How it's taken
- A single IV infusion of the patient's own engineered T cells, given once at a treatment center
Carvykti (ciltacabtagene autoleucel) is a one-time CAR T cell therapy, made from a person's own T cells, for adults with relapsed or refractory multiple myeloma[1].
- The current label covers adults who have had at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and whose myeloma is refractory to lenalidomide[1].
- The FDA first approved Carvykti on February 28, 2022, after 4 or more prior lines, and moved it to earlier use on April 5, 2024[2].
- In the CARTITUDE-4 trial, 75.9% of people on Carvykti were alive without progression at 12 months, against 49.5% on standard therapy[1].
- Carvykti carries a boxed warning for cytokine release syndrome, nerve toxicities including parkinsonism, HLH/MAS, low blood counts, gut inflammation and secondary blood cancers, including T-cell cancers[1].
- Carvykti is not approved for newly diagnosed myeloma, and the FDA ended its REMS safety program in June 2025[1][3].
We'll email you when Carvykti's FDA label changes, when the FDA acts on it, and when new trials for Multiple Myeloma open. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
We never share your email. Unsubscribe anytime. Privacy policy · Check any health site
Where Ciltacabtagene autoleucel fits
The label limits Carvykti to adults with relapsed or refractory myeloma after at least 1 prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent, whose disease is refractory to lenalidomide[1]. It is given once, on its own, after lymphodepleting chemotherapy, rather than as part of a continuing combination[1]. Its approval as early as second line rests on CARTITUDE-4, where the comparison was against pomalidomide-based triplets[1].
How Ciltacabtagene autoleucel works
Carvykti is a CAR T cell therapy, a living treatment built from the patient's own immune cells[1]. Doctors collect T cells from the blood, and a lab adds a gene for a chimeric antigen receptor (CAR), a new surface receptor that recognizes B-cell maturation antigen (BCMA)[1]. BCMA is a protein found on myeloma cells[1].
The Carvykti receptor has 2 BCMA-binding domains, designed to grip BCMA strongly, plus signaling parts called 4-1BB and CD3-zeta that switch the T cell on[1]. When the engineered cells meet a cell carrying BCMA, they multiply and kill it[1]. The cells are given back as a single infusion, so Carvykti is a one-time treatment rather than a repeating course[1].
Side effects and safety
- Increased early deaths. In CARTITUDE-4, 14% of the Carvykti arm died in the first 10 months against 12% on standard therapy, from myeloma progression and side effects.
- Cytokine release syndrome. Occurred in 84%, with a median onset of 7 days after infusion; grade 3 or higher in 4%.
- Nerve toxicities. Occurred in 24%, including ICANS, parkinsonism, Guillain-Barre syndrome, peripheral neuropathy, cranial nerve palsies and immune-mediated myelitis; some start weeks or months after infusion.
- HLH/MAS. A severe immune overactivation occurred in 1%, always alongside CRS, and has been fatal.
- Prolonged and recurring low blood counts. Grade 3 or higher low counts were unresolved at day 30 in 62%, and many people had counts drop again after recovering.
- Infections. Occurred in 57%, grade 3 or higher in 24%, with grade 5 (fatal) infections in 5%.
- Low antibody levels. IgG fell below 500mg/dL in 93% of patients; the label advises IVIG when IgG is below 400mg/dL.
- Allergic reactions. Occurred in 5%, all grade 2 or lower; the cell bag contains DMSO, which may cause serious reactions.
- Immune effector cell-associated enterocolitis. Severe or long-lasting diarrhea, belly pain and weight loss in the months after infusion; deaths from perforation or sepsis have occurred.
- Secondary cancers. Myeloid cancers occurred in 5% of trial patients; T-cell cancers, including CAR-positive tumors, can appear weeks after infusion. The label calls for life-long monitoring.
- Daily checks for at least 7 days after infusion for CRS and nerve problems
- Stay near a healthcare facility for at least 2 weeks after infusion
- No driving for at least 2 weeks after infusion
- Blood counts before and after infusion
- Immunoglobulin (IgG) levels after treatment
- Watch for movement, speech, handwriting or personality changes for months after infusion
- Life-long monitoring for secondary cancers
Carvykti has a boxed warning, the FDA's strongest label warning, covering several serious risks[1]:
- Cytokine release syndrome (CRS), a body-wide inflammatory reaction with fever and low blood pressure, occurred in 84% of 285 people in the CARTITUDE-1 and CARTITUDE-4 studies, and was grade 3 or higher in 4%[1].
- Nerve toxicities occurred in 24%, including ICANS (confusion, trouble speaking) in 13%, cranial nerve palsy in 7%, peripheral neuropathy in 7% and parkinsonism in 3%[1].
- Parkinsonism started a median of 56 days after infusion and resolved in only 1 of 8 people who had it[1].
- Grade 3 or higher low blood counts still present 30 days after infusion affected 62%, and counts can drop again after recovering[1].
- Immune effector cell-associated enterocolitis (IEC-EC), a severe gut inflammation with long-lasting diarrhea, has caused deaths from perforation or sepsis[1][4].
- Myeloid blood cancers (MDS or AML) occurred in 5% of trial patients, and T-cell cancers have been reported after BCMA and CD19 CAR T therapies, including Carvykti[1].
Infections occurred in 57%, including grade 3 or higher in 24%, and the label says fatal COVID-19 infections were more common than with standard therapy[1]. Low antibody levels (hypogammaglobulinemia) were seen in 94% by lab test or as a side effect[1].
In CARTITUDE-4, 14% of people randomized to Carvykti died in the first 10 months against 12% on standard therapy[1]. Of those 29 early deaths, 10 happened before the Carvykti infusion, all from myeloma progression[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Ciltacabtagene autoleucel
Carvykti is made individually for each patient, so treatment happens in steps at a treatment center[1]:
- Leukapheresis: white blood cells are collected from the blood and shipped for manufacturing[1].
- Bridging therapy: many people receive other myeloma treatment while they wait for their cells[1].
- Lymphodepletion: cyclophosphamide 300mg/m2 and fludarabine 30mg/m2 by IV daily for 3 days make room for the new cells[1].
- Infusion: a single IV dose of 0.5 to 1.0 million CAR-positive T cells per kg of body weight, up to 100 million cells, 5 to 7 days after lymphodepletion starts[1].
Before the infusion, people get acetaminophen and an antihistamine, and the center must have tocilizumab on hand for CRS[1]. In CARTITUDE-4, the median time from first cell collection to infusion was 79 days[1].
After the infusion, the label calls for daily monitoring for at least 7 days and asks patients to stay near a healthcare facility for at least 2 weeks[1]. Patients are told not to drive for at least 2 weeks[1]. The label notes an 18% manufacturing failure rate in the CARTITUDE-1 study, and a second manufacturing attempt may be made[1].
The Carvykti REMS, a restricted safety program that required hospitals to be specially certified, was eliminated by the FDA on June 26, 2025[3]. The current label lists no REMS[1].
Availability and cost
Only available as the brand-name product.
Help paying for Carvykti
The maker of Carvykti publishes no copay card, but its support program can check your insurance and explain any help that exists. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 5 charity funds for Multiple Myeloma, 1 was open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Travel help
MyCARVYKTI, sponsored by Johnson & Johnson and Legend Biotech, may help eligible patients and their care partners with transportation, lodging, meals and other out-of-pocket travel expenses for leukapheresis, bridging therapy and infusion at an Activated Treatment Center. Patients must be prescribed Carvykti, meet distance and income criteria, and live in the United States or its territories. The program is available to eligible patients regardless of insurance coverage.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance · source - Insurance and case manager help
To check eligibility, call MyCARVYKTI at 800-559-7875, option 1, Monday to Friday, 8 AM to 8 PM ET, as soon as Carvykti is prescribed. The healthcare team can also make a referral.
The official page does not say who qualifies. Ask the program. · source
Good to know: MyCARVYKTI covers travel-related costs only. Support applies only while the patient and care partners stay at or near the Activated Treatment Center for the listed treatment trips. The patient page does not describe a copay or free-drug program for Carvykti itself.
Charity funds for Multiple Myeloma
- From a charity · HealthWell FoundationMultiple Myeloma (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
CARTITUDE-4 (NCT04181827) randomized 419 adults whose myeloma was refractory to lenalidomide after 1 to 3 prior lines[1][5]. Half received Carvykti and half received standard therapy, either daratumumab, pomalidomide and dexamethasone or bortezomib, pomalidomide and dexamethasone[1].
Results at a median follow-up of 15.9 months, from the label[1]:
At a second interim analysis with a median follow-up of 33.6 months, overall survival was longer with Carvykti (hazard ratio 0.55)[1][4]. More people in the Carvykti arm died during the first 10 months, before the survival curves separated[1].
CARTITUDE-1 (NCT03548207) was the single-arm study behind the 2022 approval[1][6]. Its 97 treated patients had a median of 6 prior lines of therapy[1]. Overall, 97.9% responded and 80.4% reached a stringent complete response[1].
Development history
Carvykti was developed by Janssen, part of Johnson & Johnson, and Legend Biotech, and the label lists Legend Biotech as a co-marketer[1]. Its approval history with the FDA:
- February 28, 2022: first approval, for relapsed or refractory myeloma after 4 or more prior lines, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody[2].
- April 5, 2024: approval moved to adults with at least 1 prior line who are refractory to lenalidomide, based on CARTITUDE-4[2][1].
- June 26, 2025: the FDA eliminated the REMS for BCMA and CD19 CAR T therapies, including Carvykti[3].
- October 10, 2025: the FDA added IEC-EC to the boxed warning and added CARTITUDE-4 overall survival data to the label[4].
With the REMS change, the label cut the stay near a healthcare facility to at least 2 weeks and the no-driving period to 2 weeks[3][1]. The FDA said makers must still run 15-year follow-up studies of secondary cancers and long-term safety[3].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Carvykti is 1 of 2 FDA-approved BCMA CAR T therapies for myeloma, alongside Abecma (idecabtagene vicleucel), and the 2 have not been compared in a head-to-head trial. Other medicines aim at BCMA in different ways, including bispecific antibodies that are given repeatedly and the antibody-drug conjugate Blenrep. Proteasome inhibitors, immunomodulatory drugs and anti-CD38 antibodies such as daratumumab come earlier in treatment, and Carvykti's label requires prior use of the first 2 classes.
Common questions about Ciltacabtagene autoleucel
▸What is Ciltacabtagene autoleucel (Carvykti)?
Carvykti (ciltacabtagene autoleucel) is a one-time CAR T cell therapy, made from a person's own T cells, for adults with relapsed or refractory multiple myeloma[1]. The current label covers adults who have had at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and whose myeloma is refractory to lenalidomide[1]. The FDA first approved Carvykti on February 28, 2022, after 4 or more prior lines, and moved it to earlier use on April 5, 2024[2]. In the CARTITUDE-4 trial, 75.9% of people on Carvykti were alive without progression at 12 months, against 49.5% on standard therapy[1]. Carvykti carries a boxed warning for cytokine release syndrome, nerve toxicities including parkinsonism, HLH/MAS, low blood counts, gut inflammation and secondary blood cancers, including T-cell cancers[1]. Carvykti is not approved for newly diagnosed myeloma, and the FDA ended its REMS safety program in June 2025[1][3].
▸How does Ciltacabtagene autoleucel work?
Carvykti is a CAR T cell therapy, a living treatment built from the patient's own immune cells[1]. Doctors collect T cells from the blood, and a lab adds a gene for a chimeric antigen receptor (CAR), a new surface receptor that recognizes B-cell maturation antigen (BCMA)[1]. BCMA is a protein found on myeloma cells[1].
The Carvykti receptor has 2 BCMA-binding domains, designed to grip BCMA strongly, plus signaling parts called 4-1BB and CD3-zeta that switch the T cell on[1]. When the engineered cells meet a cell carrying BCMA, they multiply and kill it[1]. The cells are given back as a single infusion, so Carvykti is a one-time treatment rather than a repeating course[1].
▸What are the side effects of Ciltacabtagene autoleucel?
Carvykti has a boxed warning, the FDA's strongest label warning, covering several serious risks[1]: Cytokine release syndrome (CRS), a body-wide inflammatory reaction with fever and low blood pressure, occurred in 84% of 285 people in the CARTITUDE-1 and CARTITUDE-4 studies, and was grade 3 or higher in 4%[1]. Nerve toxicities occurred in 24%, including ICANS (confusion, trouble speaking) in 13%, cranial nerve palsy in 7%, peripheral neuropathy in 7% and parkinsonism in 3%[1]. Parkinsonism started a median of 56 days after infusion and resolved in only 1 of 8 people who had it[1]. Grade 3 or higher low blood counts still present 30 days after infusion affected 62%, and counts can drop again after recovering[1]. Immune effector cell-associated enterocolitis (IEC-EC), a severe gut inflammation with long-lasting diarrhea, has caused deaths from perforation or sepsis[1][4]. Myeloid blood cancers (MDS or AML) occurred in 5% of trial patients, and T-cell cancers have been reported after BCMA and CD19 CAR T therapies, including Carvykti[1].
Infections occurred in 57%, including grade 3 or higher in 24%, and the label says fatal COVID-19 infections were more common than with standard therapy[1]. Low antibody levels (hypogammaglobulinemia) were seen in 94% by lab test or as a side effect[1].
In CARTITUDE-4, 14% of people randomized to Carvykti died in the first 10 months against 12% on standard therapy[1]. Of those 29 early deaths, 10 happened before the Carvykti infusion, all from myeloma progression[1].
▸How is Ciltacabtagene autoleucel taken?
Carvykti is made individually for each patient, so treatment happens in steps at a treatment center[1]:
- Leukapheresis: white blood cells are collected from the blood and shipped for manufacturing[1].
- Bridging therapy: many people receive other myeloma treatment while they wait for their cells[1].
- Lymphodepletion: cyclophosphamide 300mg/m2 and fludarabine 30mg/m2 by IV daily for 3 days make room for the new cells[1].
- Infusion: a single IV dose of 0.5 to 1.0 million CAR-positive T cells per kg of body weight, up to 100 million cells, 5 to 7 days after lymphodepletion starts[1].
Before the infusion, people get acetaminophen and an antihistamine, and the center must have tocilizumab on hand for CRS[1]. In CARTITUDE-4, the median time from first cell collection to infusion was 79 days[1].
After the infusion, the label calls for daily monitoring for at least 7 days and asks patients to stay near a healthcare facility for at least 2 weeks[1]. Patients are told not to drive for at least 2 weeks[1]. The label notes an 18% manufacturing failure rate in the CARTITUDE-1 study, and a second manufacturing attempt may be made[1].
The Carvykti REMS, a restricted safety program that required hospitals to be specially certified, was eliminated by the FDA on June 26, 2025[3]. The current label lists no REMS[1].
▸Is Ciltacabtagene autoleucel FDA approved?
Yes, Ciltacabtagene autoleucel (Carvykti) is FDA approved (2022) for the treatment of Multiple Myeloma.
▸How long does Carvykti take to work?
In CARTITUDE-1, the median time to first response was 1 month after the Carvykti infusion[1].
Wait before infusion: In CARTITUDE-4, the median time from first cell collection to infusion was 79 days, and many people got bridging therapy while waiting[1].
Durability: In CARTITUDE-1, an estimated 60.3% of responders were still responding at 24 months[1].
Source: Carvykti prescribing information (DailyMed)
▸Does Carvykti still require a REMS program?
No, the FDA eliminated the Carvykti REMS on June 26, 2025, and the current label lists no REMS[3][1].
What changed: Hospitals no longer need special REMS certification, and the label cut the stay near a healthcare facility to at least 2 weeks[3].
Driving: The label now advises no driving for at least 2 weeks after the infusion[1].
Still required: Daily monitoring for at least 7 days after infusion remains on the label[1].
Source: FDA safety communication, June 26, 2025; Carvykti prescribing information (DailyMed)
▸Can Carvykti cause Parkinson's-like symptoms?
Yes, the Carvykti label lists parkinsonism as a boxed warning risk, seen in 3% of 285 trial patients[1].
Timing: It started a median of 56 days after infusion, and as late as 914 days[1].
Recovery: It resolved in 1 of 8 people who had it[1].
Signs: The label lists tremor, small handwriting, slow movement, stiffness, a shuffling walk and personality changes[1].
Source: Carvykti prescribing information (DailyMed)
▸Can Carvykti cause another cancer?
Yes, the Carvykti boxed warning includes secondary blood cancers, including MDS, AML and T-cell cancers[1].
Trial rate: Myeloid cancers (MDS or AML) occurred in 5% of 285 patients, a median of 447 days after treatment[1].
T-cell cancers: These have been reported after BCMA and CD19 CAR T therapies, including Carvykti, and can appear weeks after infusion[1].
Monitoring: The label calls for life-long monitoring for secondary cancers[1].
Source: Carvykti prescribing information (DailyMed)
▸How much does Carvykti cost?
A price is not stated on the Carvykti label, and Trial Friend lists only prices published by the company or a government source.
Travel help: The MyCARVYKTI program may cover travel, lodging and meals for eligible patients and care partners[7].
Phone: MyCARVYKTI can be reached at 800-559-7875, option 1[7].
Source: MyCARVYKTI Patient Support Program page
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed (Janssen Biotech, Inc.) · 2026-08. CARVYKTI (ciltacabtagene autoleucel) suspension for intravenous infusion, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2
- U.S. Food and Drug Administration, Center for Biologics Evaluation and Research · 2025-10-10. CARVYKTI (STN 125746): indications, approval letters and supporting documents. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/carvykti
- U.S. Food and Drug Administration · 2025-06-26. FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
- U.S. Food and Drug Administration · 2025-10-10. FDA approves labeling changes that include a Boxed Warning for Immune Effector Cell-associated Enterocolitis following treatment with Ciltacabtagene Autoleucel (CARVYKTI). https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-labeling-changes-include-boxed-warning-immune-effector-cell-associated-enterocolitis
- ClinicalTrials.gov · 2026-11. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against BCMA, Versus PVd or DPd in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://clinicaltrials.gov/study/NCT04181827
- ClinicalTrials.gov · 2026-11. A Study of JNJ-68284528, a CAR-T Therapy Directed Against BCMA in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). https://clinicaltrials.gov/study/NCT03548207
- Janssen Biotech and Legend Biotech · 2026-11. Patient Support Program, CARVYKTI (ciltacabtagene autoleucel). https://www.carvykti.com/patient-support-program/