The 8 Steps of CAR T-Cell Therapy

Summary

This transcript outlines the process of CAR T-cell therapy, from patient identification to infusion. It describes steps such as apheresis (collecting T cells), freezing and transporting them to Novartis for modification, and returning them to the hospital for infusion. The patient undergoes chemotherapy to prepare for the new cells, which are infused in a short procedure. A key risk is cytokine release syndrome, potentially requiring intensive care. The patient is monitored closely for 35 days to ensure stability before discharge.

Takeaways

• 🧑‍⚕️ The first step in the CAR T-cell process is identifying the patient and ensuring that CAR T-cell therapy is appropriate for them.
• 💉 A line needs to be placed in a large vein to collect the patient's T cells through an operative procedure.
• 🔄 The apheresis procedure separates T lymphocytes from the blood, collecting a prescribed dose while returning other blood components.
• 🔬 After collecting T cells, they are counted to determine if they meet the required amount. If not, a second collection may be done.
• ❄️ The collected cells are sent to the Dana-Farber cell manipulation facility for freezing, packaging, and preparation for shipment to Novartis.
• ⏳ Novartis takes 24 to 28 days to modify and prepare the T cells for return to the medical facility, where they are kept frozen until needed.
• 🏥 When ready, the patient undergoes five days of chemotherapy conditioning to clear space for the new T cells.
• 🩸 The CAR T cells, specifically Kymriah, are infused into the patient over a 30-minute period.
• ⚠️ There is a risk of cytokine release syndrome post-infusion, which may require intensive care if the patient becomes critically ill.
• 🕒 The risk window for developing cytokine release syndrome is three to 22 days after infusion, and if the patient remains stable until day 35, they can safely be discharged.

Q & A

What is the first step in the CAR T-cell process?

The first step is to identify the patient and ensure that CAR T-cell therapy is the appropriate treatment for them.

What procedure is required to collect the patient’s T cells?

The patient must undergo an operative procedure to place a large-bore IV in a major vein for the collection of T cells.

How does the apheresis machine work during T-cell collection?

The apheresis machine is a centrifuge that separates T lymphocytes from the patient's blood and returns the other blood products.

What happens if the first day of apheresis doesn't yield enough cells?

If the cell count is insufficient after the first day, the patient will undergo another round of apheresis on day two.

Where are the collected T cells sent after the apheresis process?

The T cells are sent to the Dana-Farber cell manipulation facility, where they are frozen, packaged, and prepared for transport to Novartis.

How long does the process take before the CAR T-cells are ready to be returned to the hospital?

The estimated time for the CAR T-cells to be processed and returned is 24 to 28 days.

What preparation does the patient undergo before receiving the CAR T-cell infusion?

The patient undergoes five days of chemotherapy conditioning to eliminate any remaining bad cells and make space for the new CAR T-cells.

What does the CAR T-cell infusion look like and how long does it take?

The CAR T-cell infusion is a small bag, about 50cc (less than two ounces), and it is infused over the course of half an hour.

What is cytokine release syndrome and when might it occur?

Cytokine release syndrome is a potential risk after CAR T-cell infusion, where the patient may become quite ill. It typically occurs within 3 to 22 days post-infusion.

What happens after the infusion if the patient develops cytokine release syndrome?

If cytokine release syndrome occurs, the patient may need to be transferred to the intensive care unit, where intensivists collaborate with the transplant team to manage the patient's care.

How long is the observation period after the CAR T-cell infusion?

Patients are observed until day 35 after the infusion. If they pass this period without complications, it is considered safe for them to go home.