The safety and efficacy of Celgene's CAR T cell therapies are under investigation and have not been established. There is no guarantee that these agents will receive health authority approval or become commercially available in any country for the uses being investigated.

Cancer Immune Response

Refresh your knowledge about the immune response to cancer, and how cancer can evade detection

CAR T Science

Learn about the science behind CAR T cell therapies

Patient Eligibility

Learn about patient selection considerations for CAR T cell therapy

B Cell Malignancies

Learn about unmet needs in select B cell malignancies

CAR T Process

Learn what the CAR T therapy process may involve for you and your patients

Considerations for appropriate patient selection

Two CAR T cell therapies have been approved in third or later line for adult patients with relapsed or refractory large B cell lymphoma, and one has been approved for pediatric and young adult patients with B cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.1-3

Patient identification

CAR T cell therapy is a novel treatment approach: it 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, severity of comorbidities, and chemoresistance status.4,5

Eligibility for ASCT may differ from eligibility for CAR T cell therapy

Patient selection considerations for CAR T cell therapy may differ from stem cell transplants—some CAR T clinical trials have included transplant-ineligible patients.6 Active clinical trials are also studying CAR T cell therapy as second-line treatment and for both transplant-eligible and -ineligible patients.7,8

Performance status

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 2.9 Patients generally range between ECOG PS Grade 0 (fully active) and Grade 1 (physically restricted and limited to light activity).8,10,11

Organ function

Patient selection may be based on adequate organ function and physiological reserve. A patient’s ability to tolerate fever and other potentially severe symptoms, such as cytokine release syndrome (CRS) and neurologic toxicity (NT) associated with CAR T cell therapy, should be determined.1,3,12

T cell count

Successful CAR T cell manufacturing requires an adequate supply of functional T cells. Prior treatment with lymphotoxic agents may have an impact on T cell health.6,12

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.13 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.13

These are not all of the patient selection considerations for CAR T cell therapy, and the considerations will differ from product to product.

Uses in patients with B cell and other malignancies continue to be investigated, evaluating the accessibility of CAR T cell therapy for more patients.7,9,10

CAR T cell therapies are being investigated in R/R B cell malignancies, including diffuse large B cell lymphoma (DLBCL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and follicular lymphoma (FL).7,9,14,15

Review currently enrolling trials for investigational CAR T cell therapies.

Visit ClinicalTrials.gov

References:

  1. News release. Silver Spring, MD: Food and Drug Administration; August 30, 2017. Accessed November 6, 2019.
  2. News release. Silver Spring, MD: Food and Drug Administration; May 1, 2018. Accessed November 6, 2019.
  3. News release. Silver Spring, MD: Food and Drug Administration; October 18, 2017. Accessed November 6, 2019.
  4. Hayden PJ, Sirait T, Koster L, Snowden JA, Yakoub-Agha I. Curr Res Transl Med. 2019;67:79-88.
  5. Okamoto S. Hematol Oncol Stem Cell Ther. 2017;10:178-183.
  6. Chavez JC, Bachmeier C, Kharfan-Dabaja MA. Ther Adv Hematol. 2018;1-20.
  7. ClinicalTrials.gov NCT03391466. Accessed September 24, 2019.
  8. ClinicalTrials.gov NCT03602612. Accessed November 6, 2018.
  9. ClinicalTrials.gov NCT02348216. Accessed November 6, 2018.
  10. ClinicalTrials.gov NCT02445248. Accessed November 6, 2018.
  11. ECOG-ACRIN.org. Accessed November 6, 2019.
  12. Maus MV, Levine BL. Oncologist. 2016;21:608-617.
  13. Beaupierre A, Lundberg R, Marrero L, Jain M, Wang T, Alencar MC. Clin J Oncol Nurs. 2019;23:27-34.
  14. Khalil DN, Smith EL, Brentjens RJ, Wolchok JD. Nat Rev Clin Oncol. 2016;13:273-290.
  15. Stenner F, Renner C. Front Oncol. 2018;8:219.

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