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 Aug 29, 2025.

What is Carvykti?

Carvykti is a personalized form of immunotherapy used to treat relapsed or refractory multiple myeloma in adults, which can be used as early as the first relapse. It is a one-time infusion made from your own white blood cells that have been trained to recognize and destroy cancer cells.

In Carvykti treatment, T cells (a type of white blood cell) are collected from your blood and modified in the lab by adding a special receptor called a chimeric antigen receptor (CAR) to their surface. This receptor is designed to recognize and attack BCMA, a protein found on multiple myeloma cells. Once modified, the T cells are multiplied in the lab and then infused back into your body as a personalized treatment.

Carvykti is a BCMA-targeted CAR-T cell therapy.

Who can have Carvykti therapy?

Carvykti's FDA approval is 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. 

How effective is Carvykti?

New data from the Phase 3 CARTITUDE-4 study (NCT04181827) demonstrated Carvykti was more effective than standard therapy.

• At 12 months, the estimated progression-free survival (PFS) rate was 75.9% with Carvykti compared to 49.5% with standard therapy. 
• In addition, 74.0% of patients treated with Carvykti achieved a complete response or better, while only 22.3% of patients on standard therapy reached that level of response. 

These response rates were assessed by an Independent Review Committee (IRC) using the International Myeloma Working Group (IMWG) criteria.

Boxed Warnings

This medicine may cause serious side effects and has boxed warnings for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome (GBS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged and/or recurrent cytopenias, and secondary hematological malignancies.

Warnings and Precautions

• Prolonged and Recurrent Cytopenias: Cytopenia is low levels of red blood cells (anemia), white blood cells (leukopenia) or platelets (thrombocytopenia). Cytopenia may occur after Carvykti infusion. Prolonged neutropenia has been associated with increased risk of infection. Blood counts should be monitored before and after the infusion.
• Infections: Patients should be monitored for signs and symptoms of infection and receive appropriate treament if necessary.
• Hypogammaglobulinemia (low levels of immunoglobulins):  Your immunoglobulin levels will be monitored and immunoglobulin replacement therapy may be considered if required.
• Hypersensitivity Reactions: Hypersensitivity reactions have occurred. Monitor for hypersensitivity reactions during infusion. ( 5.8)
• Secondary Malignancies: Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including this medicine. Contact Janssen Biotech, Inc. at 1-800-526-7736, if this occurs.

Carvykti side effects

Carvykti common side effects

Carvykti Common side effects may include:

• confusion, cough, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired;
• headache, dizziness;
• problems with speech;
• low blood cell counts;
• fever, chills, tiredness, or other signs of infection;
• decreased appetite, constipation, nausea or diarrhea; or
• pain in your joints or muscles.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

A serious side effect of Carvykti is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: 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 available to quickly treat CRS if it occurs.

Also, call your doctor at once if you have:

• confusion, loss of consciousness, seizures, problems with speech, reading, or writing, depression;
• tingling and numbness of hands and feet, leg and arm weakness, facial numbness; or
• low blood cell counts - fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

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.

How should I receive Carvykti?

The Carvykti treatment process involves:

1. T-cell collection – A patient’s white blood cells (T cells) are collected via leukapheresis.
2. Genetic modification – The T cells are engineered to express a CAR that recognizes BCMA, a protein highly expressed on multiple myeloma cells.
3. Expansion and conditioning – The modified T cells are multiplied in a lab, while the patient undergoes lymphodepleting chemotherapy to prepare for infusion.
4. One-time infusion – The patient receives an intravenous (IV) infusion of Carvykti.
5. Post-treatment monitoring – Patients are closely monitored for cytokine release syndrome (CRS) and other potential side effects.

Dosing information

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.

General dosing information:

• 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.

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.

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).

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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