Confirming patient suitability 

Treating hospital: haematologist, oncologist, nurse, and wider multidisciplinary team 

Once a referral is made, the treating physician will assess the patient’s suitability for YESCARTA^®/TECARTUS^® treatment. In addition to the eligibility criteria mentioned in Selection of Patients, patient evaluation includes ^{1 2 3}

Physical examination and disease assessment 

• Review of medical history including comorbidities, previous therapies, and adverse events 
• Checks for active infection and screening for infection markers (including hepatitis B virus, hepatitis C virus, and HIV) 
• Confirming whether the patient has had a live viral vaccine in the 6 weeks preceding anticipated conditioning treatment 
• Full blood count with differential  
• Chemistry panel and urinalysis 
• Assessment of venous access 
• Pregnancy status 

Collaboration of the multidisciplinary team

Treating hospital: haematologist, oncologist, nurse, and wider multidisciplinary team

The YESCARTA^®/TECARTUS^® treatment process requires close collaboration between multiple specialists and departments in the treating hospital, as well as coordination with the referring physician. Following referral, the CAR T treatment team carefully plans the patient’s care and flow with support from Kite on manufacturing times.  

A CAR T specialized physician, CAR T trained nurse and CAR T coordinator form the core team. They work together with additional healthcare professionals from the lymphoma treatment and transplantation units, apheresis unit, cell therapy laboratory and facility, pharmacy, and outpatient clinics to journey the patient through the CAR T treatment process. For patient safety, the intensive care unit and neurology are on hand during the treatment period.  

All healthcare professionals involved in YESCARTA^®/TECARTUS^® prescription, dispensing, and administration have completed a specific educational program designed to minimize risks to patients.² 

Coordination with YESCARTA^®/TECARTUS^® manufacturer Kite

Treating hospital: haematologist, oncologist, and CAR T coordinator 

YESCARTA^®/TECARTUS^® manufacture and delivery requires close coordination between the treating hospital and Kite. This process is managed through the Kite Konnect® online portal with the support of dedicated Kite case managers. The CAR T treatment team kicks off the YESCARTA^®/TECARTUS^® manufacturing process by enrolling the patient on Kite Konnect^® and asking for a leukapheresis date. Once the patient’s information and leukapheresis date is verified, the cell order is completed. 

Providing patients with information and managing expectations

Treating hospital: haematologist, oncologist, and nurse 

The CAR T treatment team provides the patient with all relevant information regarding YESCARTA^®/TECARTUS^® to support his or her decision on whether to proceed and to manage expectations.² Topics covered include: 

• how CAR T treatment works 
• the potential risks and benefits of YESCARTA^®/TECARTUS^® treatment 
• the steps of YESCARTA^®/TECARTUS^® treatment, from leukapheresis through to follow up 
• important risk minimization steps that the patient must take (including staying near the treating hospital for 4 weeks after infusion).   

Planning leukapheresis

Treating hospital: haematologist and oncologist 

The treating physician — in consultation with the apheresis unit and Kite — will carefully consider the patient’s clinical management and timing of leukapheresis to optimize cell collection.^4,5 This is important because the manufacture of YESCARTA^®/TECARTUS^® relies on the provision of sufficient viable T cells.¹ 

The physician and apheresis unit will plan how to overcome challenges of leukapheresis such as:⁵

• possible low lymphocyte levels  
• the effect of underlying disease or prior treatment on properties of the lymphocytes 
• complications such as infection, which can reduce patient suitability  

The treating physician will consider an appropriate washout period for previous therapies, which could be days or weeks depending on which therapies the patient is receiving or has received.¹ 

Despite the challenges of cell collection, CAR T manufacture has been shown to be possible even for patients with low lymphocyte counts.¹ YESCARTA^®/TECARTUS^® manufacture was successful for 110 out of 111 patients in a clinical trial setting.⁶

References

1. Korell F, et al. Current challenges in providing good leukapheresis products for manufacturing of CAR T cells for patients with relapsed/refractory NHL or ALL. Cells 2020;9:1225. 
2. Yescarta SmPC 
3. Protocol for Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med 2017;377:2531-44. 
4. McGuirk J, et al. Building blocks for institutional preparation of CTL019 delivery. Cytotherapy 2017;19:1015-24. 
5. Allen ES, et al. Autologous lymphapheresis for the production of chimeric antigen receptor (CAR) T cells. Transfusion 2017;57:1133-41. 
6. Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med 2017;377:2531-44