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Treatment Process | CARVYKTI® (ciltacabtagene autoleucel) HCP

In relapsed or refractory multiple myelomaa

Determine if CARVYKTI® is Right For Your Patient1

Key eligibility criteria from CARTITUDE-1a

  • Patients with relapsed or refractory multiple myeloma who have previously been treated with four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
  • Clinically fit patients (eg, good performance status and adequate organ function)b
  • No prior treatment with an anti-BCMA targeting agent or CAR-T directed at any target

Clinical factors

  • Biomarker testing not required
  • Prior ASCT not required
  • No age restrictions for adults
  • In the pivotal CARTITUDE-1 study, patients were not excluded based on tumor burden

ASCT=autologous stem cell transplant; BCMA=B cell maturation antigen; CAR-T=chimeric antigen receptor-T cell; CD38=cluster of differentiation 38; CNS=central nervous system.

aSee key eligibility criteria from CARTITUDE-1.

bIn the pivotal CARTITUDE-1 study, patients were excluded from the trial due to any of the following: known active or prior history of significant CNS disease, including CNS multiple myeloma; plasma cell leukemia; allogeneic stem cell transplant ≤6 months before apheresis or ongoing treatment with immunosuppressants; creatinine clearance <40 mL/min; absolute lymphocyte concentration <300/μL; absolute neutrophil count <750 cells/mm3; platelet count <50,000/mm3; hepatic transaminases >3× the upper limit of normal; cardiac ejection fraction <45%; active serious infection; prior treatment with CAR-T directed at any target; or prior therapy targeting BCMA.

Please see CARTITUDE-1 patient eligibility and exclusion criteria.

Treatment with CARVYKTI®1

CARVYKTI® Certified Treatment Center or manufacturing site

Collaboration between primary oncology center and Certified Treatment Center

Leukapheresis
Patient immune cells are extracted over the course of 3 to 6 hours. The immune cells are then cryopreserved and sent to the manufacturing site. Leukapheresis is likely to be performed at the CARVYKTI® Certified Treatment Center.
Bridging Therapy
Patients may receive additional therapy for disease control before their treatment with CARVYKTI® at the discretion of the Certified Treatment Center physician, who may consult with the primary oncologist.
Manufacturing

T cells are isolated after the cryopreserved leukapheresis material is thawed, and genetically modified to express the CARVYKTI® CAR. After quality control release, CARVYKTI® CAR-T cells are cryopreserved and returned to the certified healthcare facility for infusion.

Target 25-day turnaround CAR-T cell manufacturing time.a

aDefined as time that elapses from receipt of apheresis at manufacturing site to quality assurance release of finished product.

Lymphodepletion
Patients are lymphodepleted with cyclophosphamide + fludarabine daily for 3 days (completed 2 to 4 days prior to infusion of CARVYKTI®).
Infusion of Car-t Cells

CARVYKTI® is administered in a single infusion that may take approximately 30-60 minutes at a CARVYKTI® Certified Treatment Center.

Patient should remain within proximity of the Certified Treatment Center for at least 4 weeks following infusion.

CARVYKTI® dose is 0.5-1.0 x 106 CAR+ viable T cells per kg body weight, with a maximum dose of 1 x 108 CAR+ viable T cells per one-time infusion.

Initial Monitoring

Patients are monitored periodically for the first 4 weeks after CARVYKTI® infusion, including daily at the certified healthcare facility for the first 10 days following CARVYKTI® infusion.

Patients are monitored long term by their primary oncology care team in collaboration with the certified healthcare facility team.

CAR=chimeric antigen receptor; CAR-T=chimeric antigen receptor-T cell.

Find a CARVYKTI® Certified Treatment Center near you

FIND A CERTIFIED TREATMENT CENTER