Pronunciation: car-vick-tee
Generic name: ciltacabtagene autoleucel
Dosage form: intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 20, 2025.

What is Carvykti?

Carvykti (ciltacabtagene autoleucel) is a CAR-T therapy used to treat relapsed or refractory multiple myeloma (RRMM), as early as first relapse. Carvykti is an infusion made from your white blood cells, which have been genetically modified to target and fight multiple myeloma cancer cells. Carvykti may help patients live longer without cancer progressing or passing away.

Carvykti is administered as a one-time infusion after the preparation of your personalized infusion.

Carvykti therapy begins with collecting your white blood cells (T cells), which are then modified to recognize and target multiple myeloma cells. These modified cells are multiplied in a lab to prepare for treatment. Before receiving your one-time Carvykti infusion, you’ll undergo a short course of pre-infusion therapy to get your body ready. After the infusion, your care team will closely monitor you. The entire Carvykti treatment process typically takes about 2 to 3 months to complete.

Carvykti FDA approval

Carvykti FDA approval was first granted on February 28, 2022, for adults with relapsed or refractory multiple myeloma who had received four or more previous treatments. This approval was based on positive results from the clinical trial CARTITUDE-1 (NCT03548207) published in The Lancet. On April 5, 2024, the FDA expanded Carvykti’s approval to include patients experiencing their first multiple myeloma relapse, following new data from the Phase 3 CARTITUDE-4 study (NCT04181827) published in the New England Journal of Medicine 

Who can receive Carvykti?

Carvykti can be used to treat adults with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. 

What is CAR-T therapy?

CAR-T therapy trains your immune system to fight cancer cells.

T cells are an essential component of the immune system, helping to fight infections and protect against disease. However, in some cancers, T cells typically do not recognize cancer cells as a threat and therefore do not respond to them. 

CAR-T therapy involves collecting a patient’s T cells and genetically modifying (training) them to recognize and target specific cancer cells. Once modified, the T cells are expanded in a laboratory and administered back to the patient through a one-time intravenous infusion.

How does Carvytki work?

Multiple myeloma cancer cells have a large amount of a protein called BCMA on their surface. In Carvykti therapy, the collected T cells are changed so that they can recognize the BCMA protein on multiple myeloma cells. After you have your Carvykti infusion, your modified T cells target, attack, and destroy the cancer cells.

Carvykti mechanism of action is a BCMA-directed, genetically modified autologous T cell immunotherapy, by modifying the patient's T cells with a transgene encoding a CAR that identifies and eliminates cells that express BCMA. After binding to BCMA-expressing cells, the CAR promotes T cell activation, expansion, and elimination of target cells.

The Carvykti treatment process

T-cell collection. A patient’s white blood cells (T cells) are collected via leukapheresis.

Genetic modification. The T cells are engineered to express a CAR that recognizes BCMA, a protein highly expressed on multiple myeloma cells.

Expansion and conditioning. The modified T cells are multiplied in a lab, while the patient undergoes lymphodepleting chemotherapy to prepare for infusion.

One-time infusion. The patient receives an intravenous (IV) infusion of Carvykti.

Post-treatment monitoring. Patients are closely monitored for cytokine release syndrome (CRS) and other potential side effects.

Carvykti REMS

Carvykti is only available through the Carvykti REMS (Risk Evaluation and Mitigation Strategy) program, a restricted program designed to manage the risk of serious side effects. The Carvykti REMS program focuses on reducing the risks of cytokine release syndrome (CRS) and neurologic toxicities. This infusion can only be administered at a REMS-certified healthcare facility that is specially certified and has on-site, immediate access to treatments (tocilizumab) and facilities that may be required. It is an autologous cell therapy, meaning it is made from the patient’s T cells, which are genetically modified to recognize and destroy multiple myeloma cancer cells.

How Well Does Carvykti Work? Results from Clinical Trials

Carvykti in the CARTITUDE-4 Clinical Trial

The CARTITUDE-4 trial results showed that 84.6% of Carvykti patients responded to treatment with:

• 65.9% had a stringent complete response – meaning no signs of cancer were found after treatment. This is the best possible outcome.
• 8.2% had a complete response, with no detectable cancer but slightly different lab findings.
• 7.7% had a very good partial response, which means the cancer was greatly reduced but not completely gone.

In CARTITUDE-4, Carvykti was tested in people with relapsed and lenalidomide-refractory multiple myeloma who have already tried treatment. This means their cancer had come back or stopped responding to certain standard treatments of a proteasome inhibitor and an immunomodulatory agent.

These results were reviewed by the Independent Review Committee (IRC) using standard guidelines from the International Myeloma Working Group (IMWG).

Carvykti in the CARTITUDE-1 Clinical Trial

The CARTITUDE-4 trial results showed 98% of patients responded to Carvykti with:

• 78% had a stringent complete response.
• 17% had a very good partial response.
• 3% had a partial response, meaning the cancer was reduced but not as much as in the other groups.

In the earlier CARTITUDE-1 clinical trial, Carvykti was tested in relapsed or refractory multiple myeloma patients who had received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

As with CARTITUDE-4, these results were reviewed using trusted international standards.

How to Access Carvykti Treatment

Carvykti is only available at Carvykti Certified Treatment Centers, which have doctors and nurses who are specially trained in delivering this CAR-T cell therapy. This team works with you and your healthcare team to coordinate your treatment. You will need to stay close to the Carvykti Certified Treatment Center for at least 4 weeks after your Carvykti treatment. For information on your closest centre, see Find a CARVYKTI® Certified Treatment Center

Is Carvykti covered by insurance?

Yes, Carvykti is covered for some patients who are eligible through their commercial insurance plans, but this does vary from plan to plan. Medicare may also cover CAR-T therapies. If you are unsure of your insurance coverage, it is best to consult your insurance provider for clarification. You will need to have your treatment in a REMS-certified facility with prior authorization

Carvykti side effects

Common Carvykti side effects

Common side effects of Carvykti include:

• Fever 79%
• Muscle and joint pain 34%
• Tiredness 28%
• Diarrhea 27%
• Headache 23%
• Low blood pressure 23%
• Nausea 20%
• Constipation 10%
• Upper respiratory tract infection 25%
• Viral infection 23%
• Bacterial infection 15%
• Cough 15%
• Pneumonia 14%
• Hypoxia - low oxygen levels 12%
• Swelling or edema 11%
• Feeling confused, agitated or not like yourself (encephalopathy) 11%
• Pain 10%
• Decreased appetite 10% 
• Hypogammaglobulinemia (Immune system disorder) 94%
• Cytokine release syndrome 78%
• Low blood test results including low lymphocytes 99%, neutrophils 95%, white blood cells 94%, platelet 47% and hemoglobin 34%.

These common side effects occurred in at least 10% of Carvykti patients in the CARTITUDE-4 clinical trial. 

Serious Side Effects

• Cytokine Release Syndrome (CRS). Tell your caregivers right away if you have signs or symptoms of fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication (tocilizumab and corticosteroids) available to quickly treat CRS if it occurs. 
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with this infusion. HLH/MAS can occur with CRS or neurologic toxicities. 
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). May cause confusion, memory loss, seizures.
• Prolonged Cytopenias. Risk of anemia, thrombocytopenia, and the need for stem cell transplantation.
• Secondary Malignancies. Increased risk of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and T-cell malignancies.
• Neurological Disorders. Reports of Parkinsonism and Guillain-Barré syndrome.

Patients should be closely monitored for any adverse reactions. Contact a healthcare provider immediately if experiencing severe side effects.

These are not all of the possible side effects of Carvykti. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

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Warnings & precautions

• Avoid Carvykti if you have an active infection or inflammatory disorder.
• Do not receive live vaccines before or after treatment.
• Drowsiness & Cognitive Impairment: Refrain from driving or operating heavy machinery for at least 8 weeks after treatment.
• Increased risk of false-positive HIV tests.
• Avoid blood, organ, or tissue donation after receiving this medicine.
• Also see the serious side effects section.

Before taking this medicine

Tell your doctor if you have ever had:

• neurologic problems (such as stroke, seizures, memory loss);
• breathing problems;
• heart problems;
• liver or kidney disease;
• recent or active infection; or
• low blood counts.

Pregnancy

Carvykti is not recommended for women who are pregnant or for women of childbearing potential not using contraception. Pregnant women should be advised that there may be risks to the fetus. Pregnancy after this therapy should be discussed with the treating physician.

Women will need pregnancy testing before receiving this medicine. You will also need to use birth control to prevent pregnancy during treatment with this medicine. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

Carvykti dosage & administration

Recommended dose: 0.5-1.0×10^6 CAR-positive viable T cells per kg, with a maximum dose of 1×10^8 CAR-positive viable T cells per infusion.

Pre-medication required: Acetaminophen and an H1-antihistamine before infusion.

Administered intravenously at an authorized facility.

Patients should stay within 2 hours of the treatment facility for at least 4 weeks post-infusion for monitoring.

Carvykti Package Insert

HCPs and patients often use the Carvykti Package Insert (PI) for more detailed information about this medicine. The Carvykti Package Insert contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the FDA label, or Carvykti Prescribing Information (PI).

What should I avoid after receiving this medicine?

• Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert for at least 8 weeks after you get Carvykti. This is because the treatment can cause memory and coordination problems, sleepiness, confusion, dizziness, seizures, or other neurologic side effects, as discussed by your healthcare provider.
• You must not be given certain vaccines called live vaccines for some time before and after Carvykti treatment. Talk to your healthcare provider if you need to have any vaccinations.
• Do not donate blood, organs, tissues, or cells for transplantation.

What other drugs will affect Carvykti?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some commercial Human Immunodeficiency Virus (HIV) tests may incorrectly give you an HIV-positive result while you are receiving treatment with Carvykti.

Ingredients

Active ingredient: ciltacabtagene autoleucel

Inactive ingredients: DMSO

Manufacturer Information

Carvykti Manufacturer Janssen Biotech, Inc., Horsham, PA, USA.

Marketing Partner Legend Biotech, Somerset, NJ, USA.

Carvykti Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Carvykti.

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Further information

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