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Carvykti is a prescription BCMA-directed genetically modified autologous T-cell immunotherapy containing ciltacabtagene autoleucel. It is approved for adults with relapsed or refractory multiple myeloma after at least one prior therapy line that included a proteasome inhibitor and an immunomodulatory agent, with disease refractory to lenalidomide. Treatment is made from the patient's own T cells.
read more about carvykti ...Carvykti T cells are genetically modified to express a chimeric antigen receptor that recognizes B-cell maturation antigen on target cells. The receptor contains two BCMA-targeting domains along with signaling components that activate the modified T cells. Binding to BCMA-expressing cells triggers T-cell expansion and destruction of those target cells.
Carvykti is approved for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy line that included a proteasome inhibitor and an immunomodulatory agent and whose disease is refractory to lenalidomide. The treatment is autologous, meaning each dose is manufactured from cells collected from the individual patient.
Carvykti is given once by intravenous infusion after lymphodepleting chemotherapy with cyclophosphamide and fludarabine. The recommended dose range is 0.5 million to 1 million CAR-positive viable T cells per kg, up to 100 million cells. Acetaminophen and an H1 antihistamine are given before infusion. Close monitoring follows treatment.
Carvykti carries boxed warnings for cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis or macrophage activation syndrome, prolonged and recurrent cytopenias, and secondary hematologic malignancies. Other concerns include infections, low immunoglobulin levels, hypersensitivity reactions, immune effector cell-associated enterocolitis, and increased early mortality observed in a clinical trial.
Yes. Carvykti is an autologous BCMA-directed CAR T-cell therapy made from the patient's own T cells.
Carvykti is administered as a single intravenous infusion after lymphodepleting chemotherapy.
Carvykti treats selected adults with relapsed or refractory multiple myeloma who meet prior-treatment and lenalidomide-resistance criteria.
Yes. Boxed warnings cover cytokine release syndrome, neurologic toxicities, HLH or MAS, prolonged cytopenias, and secondary hematologic malignancies.
CARVYKTI (ciltacabtagene autoleucel) Package Insert and Medication Guide. https://www.fda.gov/media/156560/download?attachment=. Date Accessed September 21, 2026.
CARVYKTI. U.S. Food and Drug Administration. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/carvykti. Date Accessed September 21, 2026.
Ciltacabtagene Autoleucel. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/drugs/ciltacabtagene-autoleucel. Date Accessed September 21, 2026.
Ciltacabtagene Autoleucel Injection. MedlinePlus. https://medlineplus.gov/druginfo/meds/a622041.html. Date Accessed September 21, 2026.
DailyMed - CARVYKTI (ciltacabtagene autoleucel) injection, suspension. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2. Date Accessed September 21, 2026.