Product infusion and recovery
Manufacturing the T-cells is an offshore activity and may take several weeks to complete. During this time, additional treatment (bridging therapy) might be necessary to keep disease under control.
Once the cells have returned from manufacturing, the patient receives treatment to dampen their immune system (lymphodepletion) and to increase the impact of the CAR T-cells. The clinical team then infuse the CAR T-cells into the patient.
Following infusion, the patient is closely monitored, and any side effects are managed. This early phase of recovery generally lasts for about a month but may last longer if complications occur.
Patients may be discharged within the month, however they are required to stay close to the hospital to get regular check-ups during this four week period. Once this period is completed, the patient should be able to go home but will need to return to the treating centre regularly for follow-up care.
CAR T-cell treatment may cause a strong reaction from the patient’s immune system. The two main side effects are:
- Cytokine release syndrome (CRS)
- Immune effector cell-associated neurotoxicity syndrome (ICANS).
Most patients will experience one or both of these side effects, which can be severe or life threatening.
Cytokine release syndrome
Symptoms of CRS may include fever, nausea, vomiting, diarrhoeia, muscle aches, headache, rash, rapid heartbeat, low blood pressure, trouble breathing and dizziness or being lightheaded.
Immune effector cell-associated neurotoxicity syndrome
Symptoms of ICANS may include encephalopathy, tremor, confusion, agitation, lower level of consciousness, seizures, speech disorders and feeling drowsy.
These side effects generally occur within the first week post-infusion but, particularly in the case of ICANS, may occur weeks later.
Patients may need to be moved to intensive care until the side effects have resolved. There are effective treatments for CRS and ICANS, but early identification and intervention is required.
There are several other side effects and adverse events observed with CAR T-cell treatments. Full details will be provided by the treating centres.