What is Carvykti?
Carvykti, also known as ciltacabtagene autoleucel or cilta-cel, is a BCMA-directed personalized immunotherapy known as chimeric antigen receptor (CAR) T-cell therapy. Carvykti is manufactured by Janssen Biotech.
Uses
How is Carvykti used?
Carvykti is used for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
What types of patients can benefit from Carvykti?
In a phase 1b/2 clinical trial, Carvykti was shown to be effective in:
Carvykti is manufactured using a patient’s T cells that have been collected from their blood. The T cells are modified in a lab with a CAR to recognize BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. CAR T cells are then infused back into the patient, where they are able to find and kill myeloma cells.
Carvykti is used for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
What types of patients can benefit from Carvykti?
In a phase 1b/2 clinical trial, Carvykti was shown to be effective in:
- Patients who received at least four prior therapies
- Patients who were refractory to their previous treatment(s)
- Patients who previously received high-dose chemotherapy and stem cell transplant
Carvykti is manufactured using a patient’s T cells that have been collected from their blood. The T cells are modified in a lab with a CAR to recognize BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. CAR T cells are then infused back into the patient, where they are able to find and kill myeloma cells.
Dosing and Administration
Carvykti is given intravenously (IV) at a one-time infusion of 0.5 to 1 × 106 CAR-positive T cells/kg of body weight 2 to 4 days after the patient completes lymphodepleting chemotherapy (cyclophosphamide 300 mg/m2 IV and fludarabine 30 mg/m2 IV for 3 days).
Side Effects
What are Carvykti side effects?
The most common side effects seen in a clinical study with Carvykti included:
How are side effects of Carvykti managed?
Approximately 30 to 60 minutes prior to Carvykti infusion, patients receive acetaminophen (fever reducer) and diphenhydramine (antihistamine). The use of dexamethasone or other systemic corticosteroids should be avoided. Patients will be monitored at least daily for 10 days following Carvykti infusion for signs and symptoms of cytokine release syndrome and neurologic toxicities. Management guidelines will be followed if cytokine release syndrome or neurologic toxicity is suspected.
The most common side effects seen in a clinical study with Carvykti included:
- Low platelet counts (thrombocytopenia)
- Low neutrophil counts (neutropenia)
- Low hemoglobin (anemia)
- Elevated aminotransferase
- Low albumin
- Fever
- Cytokine release syndrome
- Hypogammaglobulinemia
- Low blood pressure
- Musculoskeletal pain
- Fatigue
- Infection
- Cough
- Chills
- Diarrhea
- Nausea
- Encephalopathy
- Decreased appetite
- Upper respiratory infection
- Headache
- Rapid heart rate
- Dizziness
- Shortness of breath
- Edema
- Viral infections
- Coagulopathy
- Constipation
- Vomiting
- Cytokine release syndrome
- Neurotoxicity, called immune effector cell-associated neurotoxicity syndrome (ICANS)
- Parkinsonism and Guillain-Barré syndrome
- Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
- Prolonged low blood counts
How are side effects of Carvykti managed?
Approximately 30 to 60 minutes prior to Carvykti infusion, patients receive acetaminophen (fever reducer) and diphenhydramine (antihistamine). The use of dexamethasone or other systemic corticosteroids should be avoided. Patients will be monitored at least daily for 10 days following Carvykti infusion for signs and symptoms of cytokine release syndrome and neurologic toxicities. Management guidelines will be followed if cytokine release syndrome or neurologic toxicity is suspected.
Clinical Studies
What have Carvykti clinical trials shown?
The approval of Carvykti was based on results from the CARTITUDE-1 trial, a single-arm, multicenter trial to determine the efficacy of Carvykti in patients with RRMM who had received at least three prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The trial enrolled 97 patients who received a single infusion of Carvykti at a target dose of 0.75 × 106 CAR-positive T cells/kg. The overall response rate was 98%, and 78% of patients achieved a stringent complete response (sCR). The median time to first response was 30 days and median duration of response was 21.8 months.
How is Carvykti currently being studied in myeloma?
Carvykti is being evaluated in several clinical trials in the U.S.
Phase 3 trials include:
Created March 2022
Please visit the sponsor’s official patient site for up-to-date information on Carvykti. www.CARVYKTI.com
The approval of Carvykti was based on results from the CARTITUDE-1 trial, a single-arm, multicenter trial to determine the efficacy of Carvykti in patients with RRMM who had received at least three prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The trial enrolled 97 patients who received a single infusion of Carvykti at a target dose of 0.75 × 106 CAR-positive T cells/kg. The overall response rate was 98%, and 78% of patients achieved a stringent complete response (sCR). The median time to first response was 30 days and median duration of response was 21.8 months.
How is Carvykti currently being studied in myeloma?
Carvykti is being evaluated in several clinical trials in the U.S.
Phase 3 trials include:
- Velcade-Revlimid-dex (VRd) followed by Carvykti vs VRd followed by Rd in patients with newly diagnosed MM for whom ASCT is not planned as initial therapy (CARTITUDE-5; NCT04923893)
- Carvykti vs Pomalyst-Velcade-dex (PVd) or Darzalex-Pomalyst-dex (DPd) in patients with relapsed and Revlimid-refractory MM (CARTITUDE-4; NCT04181827)
- A multicohort study evaluating the safety and efficacy of Carvykti in various clinical settings (CARTITUDE-2; NCT04133636)
Created March 2022
Please visit the sponsor’s official patient site for up-to-date information on Carvykti. www.CARVYKTI.com
