CARVYKTI (ciltacabtagene autoleucel)

What Is Carvykti?

Carvykti™ (ciltacabtagene autoleucel, cilta-cel) is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell immunotherapy that has recently received approval from the FDA based on data from the Phase 1b/2 CARTITUDE-1 study. Carvykti is a personalized immune cell therapy delivered as a one-time infusion, manufactured for each individual patient using the patient’s own white blood cells (T cells).

Who Is a Candidate for Carvykti?

Carvykti is approved for use in adult patients with relapsed (myeloma that has come back after prior treatment was stopped) or refractory (myeloma that is no longer responsive to prior treatments) multiple myeloma, who have had four or more prior lines of therapy, including:

  • a proteasome inhibitor (e.g., bortezomib, carfilzomib, or ixazomib), 
  • an immunomodulatory agent (e.g., lenalidomide or pomalidomide), and 
  • an anti-CD38 monoclonal antibody (e.g., daratumumab or isatuxiumab). 

It is for autologous use only, meaning your own T cells will be extracted, genetically modified, and infused back into you. Your personal T cells cannot be given to another patient.

UPDATE: On April 5, 2024, the FDA approved Carvykti for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy, including an immunomodulatory agent and a proteasome inhibitor, and are refractory to Revlimid. Carvykti is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the  treatment of patients with myeloma as early as first relapse.The new FDA approval is based on data from the CARTITUDE-4 phase III clinical trial. Visit this press release on Carvykti to learn more. 

How Does Carvykti Work?

Carvykti recognizes and binds to BCMA, a protein that is almost universally found on myeloma cells. This leads to the removal of BCMA-expressing cells, thereby, removing the cancer cells. Your own T cells are genetically modified to recognize and attack BCMA on the surface of the myeloma cells present in your own body.

How is Carvykti Given?

Before giving you Carvykti, your doctor will prepare your body by giving you chemotherapy for three days. On the day you receive Carvykti, your doctor will give you acetaminophen (e.g., Tylenol) and an antihistamine (e.g., Benadryl) 30 to 60 minutes before your Carvykti dose.

Carvykti is given as a single-dose IV (into the vein) infusion at a certified healthcare facility, which should take no more than 2.5 hours to receive. You will be monitored daily for 10 days following the infusion at the healthcare facility. After that, you should remain close to the same healthcare facility for 4 weeks as you will continue to be monitored occasionally.  

Important Safety Information

Carvykti can cause reactions that can be fatal and life-threatening. You should not receive Carvykti if you have an active infection or an inflammatory disorder. For your safety, you will be monitored for neurological events after treatment and may be prescribed corticosteroids, if needed.

You will be instructed not to drive or operate heavy or dangerous machinery for at least 8 weeks following infusion.

Possible Side Effects

The CARTITUDE-1 study showed a consistent safety profile for Carvykti. Your doctor will check to see that your treatment is working and help you with any side effects that may occur. Your doctor may give you other medicines to treat your side effects.

The most common side effects of Carvykti are fever, cytokine release syndrome (a type of systemic inflammation), hypogammaglobulinemia (low antibody levels), low blood pressure, musculoskeletal pain, fatigue, infections, cough, chills, diarrhea, nausea, encephalopathy (damage or disease of the brain), decreased appetite, upper respiratory tract infection, headache, rapid heart beat, dizziness, shortness of breath, swelling, viral infections, coagulopathy (bleeding disorder), constipation, and vomiting. 

Other common side effects include thrombocytopenia (low platelet levels), neutropenia (low levels of white blood cells), anemia (low levels of red blood cells), aminotransferase elevation (increase in liver enzymes) and hypoalbuminemia (low levels of albumin, a protein in the blood).

Having Carvykti in your blood may cause a false-positive human immunodeficiency virus (HIV) test result by some commercial tests.

Support

Carvykti is currently only administered at certified treatment centers, and appropriate use of Carvykti is supported by the Carvykti Risk Evaluation and Mitigation Strategy (Carvykti REMS) program. For more information, please visit https://www.carvyktirems.com or call 1-844-672-0067. 

Additional Resources: 

U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Highlights of Prescribing Information for CARVYKTI™

From Best of 2021 ASH to 2022 COVID-19 Guidance

Updated Results from CARTITUDE-1: Phase 1b/2Study of Ciltacabtagene Autoleucel in Patients with Relapsed Refractory Multiple Myeloma

New Data from CARTITUDE-1 Study Show Continued Deep and Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) in Treatment of Heavily Pretreated Patients with Multiple Myeloma

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1)


 


 


The International Myeloma Foundation medical and editorial content team

Comprised of leading medical researchers, hematologists, oncologists, oncology-certified nurses, medical editors, and medical journalists, our team has extensive knowledge of the multiple myeloma treatment and care landscape. Additionally, Dr. Brian G.M. Durie reviews and approves all medical content on this website. 

Last Medical Content Review: March 3, 2022

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Source URL: https://www.myeloma.org/treatment/carvykti-ciltacabtagene-autoleucel