ciltacabtagene autoleucel (Carvykti)

Indications

• treatment of adult patients with relapsed or refractory multiple myeloma after >= prior lines of therapy, including:
  • a proteasome inhibitor
  • an immunomodulatory agent
  • an anti-CD38 monoclonal antibody.

* for autologous use only

Dosage

• administer a lymphodepleting regimen of cyclophosphamide & fludarabine before infusion
• do NOT use a leukodepleting filter
• premedicate with acetaminophen & an H1-antihistamine
• confirm availability of tocilizumab prior to infusion

• 0.5-1.0 x 10E6 CAR-positive viable T-cells/kg
• maximum: 1 X 10E8 CAR-positive viable T-cells per infusion

Adverse effects

• cytokine release syndrome
• prolonged & recurrent cytopenias
• hypogammaglobulinemia

* Box warning:

• immune effector cell-associated enterocolitis
  • life-threatening & fatal cases from gut perforation & sepsis

Mechanism of action

• B-cell maturation antigen-directed genetically modified autologous T-cell immunotherapy

More general terms

• chimeric antigen-receptor (CAR) T-cell therapy