CAR T cell therapies have been approved for adult, pediatric, and young adult patients with certain relapsed or refractory cancers.
CAR T cell therapy is generally an autologous cell therapy that may have different patient selection considerations than autologous stem cell transplant (ASCT); some examples include prior lines of therapy, upper age limit, patient fitness, severity of comorbidities, and chemoresistance status.
- Tumor expressing a CAR target (eg, BCMA, CD19, CD20, CD22, CD23, ROR1, and the kappa light chain)
- Adequate number of T cells for collection
- No active, uncontrolled infections, including hepatitis B, hepatitis C, or HIV
- Adequate performance status and organ function
- Absence of clinically relevant comorbidities (eg, select cardiovascular, neurologic, or immune disorders)
BCMA, B-cell maturation antigen; CD19/CD20/CD22/CD23, B-lymphocyte antigen CD19/CD20/CD22/CD23.
Precise criteria for eligibility vary by
- Treatment regimen or protocol
- CAR T cell product
Patient selection considerations for CAR T cell therapy may differ from stem cell transplants—some CAR T clinical trials have included transplant-ineligible patients.
Considerations for Patients Treated With CAR T Cell Therapy
Eastern Cooperative Oncology Group performance status (ECOG PS) is often used to determine patient eligibility for CAR T cell therapy. Some investigational trials have included patients with ECOG PS Grade 2.
Patient selection may be based on adequate organ function and physiological reserve. A patient’s ability to tolerate fever and other potentially severe adverse reactions, such as cytokine release syndrome (CRS) and neurological toxicity (NT) associated with CAR T cell therapy, should be determined.
T cell health
Patients who are earlier in their disease tend to have healthier T cell populations, which may help improve the chances of manufacturing success of CAR T cell products and also help drive CAR T cell expansion and persistence following infusion. Multiple lymphotoxic treatments, such as cyclophosphamide, venetoclax, bendamustine, and dexamethasone, may compromise T cell health and limit the ability to generate viable CAR T cells.
Accessibility and support
Insurance coverage and ability to travel to an authorized treatment center, as well as having an adequate patient support network, are key considerations in patient selection. CAR T cell therapy is an involved process, making it necessary for patients to have competent and committed caregiver support.
These are not all of the patient selection considerations for CAR T cell therapy, and the considerations will differ from product to product.
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