Some CAR T therapies are approved and some are being investigated in clinical trials.

CAR T Cell Therapy Process

Facilitating access to CAR T cell therapy

Close collaboration between patient and healthcare team is critical for CAR T cell therapies.1

Once a potential patient is identified for CAR T cell therapy, the next step is to connect with an authorized treatment center to initiate the screening and enrollment process as appropriate. The authorized treatment center will determine patient eligibility and may offer assistance in securing insurance approval and providing counseling to the patient and caregiver.1

An important part of getting patients a step closer to CAR T cell therapy is to consider patient logistics. Some patients may need to travel to a treatment center to receive CAR T cell therapy. Patients will be required to remain within close proximity to the center throughout the process and for a period of time after receiving CAR T cell therapy to monitor for adverse reactions. As a result, logistical or financial support may be available to eligible patients with the need to remain in proximity to the treatment center following CAR T cell therapy.1,2

CAR T Cell Therapy Process

Figure illustrating the 4 steps of CAR T cell therapy: leukapheresis, manufacturing, infusion, and monitoringFigure illustrating the 4 steps of CAR T cell therapy: leukapheresis, manufacturing, infusion, and monitoring

T cells are collected via leukapheresis.

Leukapheresis

Creation of chimeric antigen receptor (CAR) T cell therapy begins with collection of the patient’s blood and separation of the lymphocytes through apheresis (leukapheresis). Clinicians coordinate collection based on the patient’s treatment regimen to ensure the presence of sufficient numbers of T cells.3 The procedure is performed at an authorized clinic or infusion center coordinated by the patient’s healthcare team.4

Learn more about T cell subtypes >
Figure illustrating the 4 steps of CAR T cell therapy: leukapheresis, manufacturing, infusion, and monitoringFigure illustrating the 4 steps of CAR T cell therapy: leukapheresis, manufacturing, infusion, and monitoring

Cells are sent to the manufacturing site for engineering and expansion and are released after quality assurance.

Manufacturing

CAR T cell engineering involves a number of steps. The apheresis product may be processed to remove any cells that inhibit T cell activation and expansion.5,6 The CAR gene construct can then be incorporated into the T cells using one of several different methods. Finally, the CAR T cells are expanded, or grown, outside the body, to an appropriate dose.7 They are released following quality assurance.1,7

Learn more about CAR T cell expansion and persistence >
Figure illustrating the 4 steps of CAR T cell therapy: leukapheresis, manufacturing, infusion, and monitoringFigure illustrating the 4 steps of CAR T cell therapy: leukapheresis, manufacturing, infusion, and monitoring

CAR T cell therapy is administered a few days after completion of lymphodepletion (eg, low-dose fludarabine and cyclophosphamide).

Infusion

The patient’s healthcare team administers conditioning chemotherapy to deplete lymphocytes before infusion with CAR T cell therapy, which may improve expansion and persistence.4 Following completion of lymphodepletion, the patient’s healthcare team administers the prepared CAR T cell therapy.1 Administration directions vary depending on the CAR T cell therapy.

Figure illustrating the 4 steps of CAR T cell therapy: leukapheresis, manufacturing, infusion, and monitoringFigure illustrating the 4 steps of CAR T cell therapy: leukapheresis, manufacturing, infusion, and monitoring

Patients are monitored frequently for signs and symptoms of CRS, NT, and other adverse events at the certified healthcare facility in the days following infusion.* Patients will remain within proximity of the healthcare facility for at least 4 weeks following infusion and undergo long-term follow-up.

*CAR T cell therapy may be administered in an outpatient setting for eligible patients.

Monitoring

Clinics may be required to implement a program to train healthcare staff who prescribe, dispense, or administer CAR T cell therapy about how to monitor, manage, and educate patients on adverse events.

Patients are monitored frequently for signs and symptoms of CRS, neurotoxicity, and other adverse events at the certified healthcare facility in the days following infusion. Patients will remain within proximity of the certified healthcare facility for at least 4 weeks following infusion and undergo long-term follow-up.8

Further information on adverse event monitoring and management can be obtained from CAR T cell therapy manufacturers or study investigators.

Learn more about CAR T associated toxicities >


References: 1. Beaupierre A, Lundberg R, Marrero L, Jain M, Wang T, Alencar MC. Clin J Oncol Nurs. 2019;23:27-34. 2. Boyiadzis MM, Dhodapkar MV, Brentjens RJ, et al. J Immunother Cancer. 2018;6-137. 3. Wang X, Rivière I. Mol Ther Oncolytics. 2016;3:16015. doi:10.1038/mto.2016.15. 4. Batlevi CL, Matsuki E, Brentjens RJ, Younes A. Nat Rev Clin Oncol. 2016;13:25-40. 5. Fesnak A, Lin C, Siegel DL, Maus MV. Transfus Med Rev. 2016;30:139-145. 6. Bryn T, Yaqub S, Mahic M, Henjum K, Aandahl EM, Tasken K. Int Immunol. 2008;20:235-245. 7. Lee DW, Barrett DM, Mackall C, Orentas R, Grupp SA. Clin Cancer Res. 2012;18:2780-2791. 8. Neelapu SS, Tummala S, Kebriaei P, et al. Nat Rev Clin Oncol. 2018;15:47-62.