Reducing the Barriers to Receiving CAR T-Cell Therapy for Patients With Hematologic Malignancies

Chimeric antigen receptor (CAR) T-cell therapy has transformed treatment for patients with hematologic malignancies, achieving unprecedented responses in some patients, especially those diagnosed with relapsed/refractory B-cell acute lymphocytic leukemia, non-Hodgkin lymphoma, and multiple myeloma.¹ Access to this high-cost, high-complexity therapy remains variable, however—and out-of-reach for many patients. According to the results from a retrospective study by Jae H. Park, MD, Chief of the Cellular Therapy Services and Attending Physician at Memorial Sloan Kettering Cancer Center (MSK), and his colleagues, one-third to one-half of patients referred to CAR T-cell therapy never receive it.²

The study evaluated the proportion of patients with a hematologic malignancy who were referred to the Cellular Therapy Service at MSK between September 1, 2021, and July 31, 2023; the reasons for patients ultimately not receiving this therapy; and disparities in accessing the treatment. Patient information was obtained from the patients’ medical records and members of the care team.

We want to overcome whatever barriers are prohibiting patients from accessing this care.

— JAE H. PARK, MD

Tweet this quote

During the study period, 400 patients were referred for CAR T-cell therapy at the cancer center. Of these patients, 197 (49%) had non-Hodgkin lymphoma, 176 (44%) had multiple myeloma, and 27 (7%) had other hematologic malignant neoplasms. Most of the patients were male (62%), aged 57 to 73 years old. Of the 372 patients with racial and ethnic data, 37 (10%) identified as Asian; 34 (9%) as Black; 294 (79%) as White; and 7 (2%) as other race and ethnicity. Overall, 369 (92%) of the patients were referred to MSK’s Cellular Therapy Service internally, and 31 (8%) were referred by oncologists outside of the institution or were self-referred.

The study results show that among the 400 participants referred to CAR T-cell therapy, 177 (44%) did not receive the treatment. Patients diagnosed with multiple myeloma, those who identified as Black, patients with worse performance status, and those who received external referrals all had lower odds of receiving CAR T-cell therapy.²

In a wide-ranging interview with The ASCO Post, Dr. Park discussed the barriers to receiving CAR T-cell therapy, especially for Black and other minority patients; the potential for the therapy to replace stem cell transplantation in some patients with hematologic malignancies; and how he and his colleagues plan to expand access to CAR T-cell treatment.

Understanding Disparities in Care for Black Patients With Myeloma

Multiple myeloma is the second most frequent hematologic malignancy diagnosed in the United States, and compared to non-Hispanic White individuals, Black men and women have a more than twofold higher incidence of developing the cancer.³ The results from your study show, among other factors, that Black race was associated with lower odds of receiving CAR T-cell therapy. Why might race be a factor in accessing this therapy?

We don’t exactly know the answer to that question. More in-depth evaluations are needed to explain why fewer Black patients with multiple myeloma receive CAR T-cell therapy compared with White patients and other ethnic and race minorities. What happened in some instances in our study was that Black patients were either offered the therapy too early after their diagnosis, meaning they didn’t meet the criteria for the treatment; or they were referred too late in their disease progression to be eligible to receive the treatment.

When patients are referred late for CAR T-cell therapy, their disease is usually so advanced, there isn’t enough time to plan for treatment, including collection of T cells and the manufacturing of the CAR T product, which can take several weeks, and subsequent infusion of the cells for the therapy to be effective. We also know that patients have better long-term outcomes if they receive CAR T-cell therapy when their disease burden is low or stable. They also experience less treatment toxicity because there is less work for the T cells to do.

There is a trend now in giving CAR T-cell therapy in earlier lines of treatment. Recently, the United States Food and Drug Administration (FDA) expanded indications for CAR T-cell therapies in earlier treatment settings for relapsed or refractory multiple myeloma, and that will help refer patients earlier to this therapy. In April 2024, the FDA approved ide-cel for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy,⁴ and cilta-cel for patients with relapsed or refractory myeloma who have received at least one prior line of therapy.⁵

Studies have shown racial disparities in access to stem cell transplantation for Black patients with multiple myeloma. For example, Black patients are about 30% less likely to receive a transplant or receive triplet induction regimens.⁶ Is race or implicit bias playing a role in determining which patients have access to stem cell transplantation and the newer cellular T-cell therapies in the treatment of hematologic malignancies?

In our study, we weren’t able to tease out the exact reasons why there was a discrepancy in the patients receiving CAR T-cell therapy. Other studies have examined socioeconomic barriers to this type of treatment., including financial constraints and lack of health insurance.

Another problem with this type of therapy is that it can not be given outside of specialized accredited treatment centers and those centers are typically concentrated in urban cities. In addition, patients undergoing this treatment had been required to stay within close distance to the treatment center for the first month following therapy and a caregiver must accompany the patient, per the FDA Risk Evaluation and Mitigation Strategies (REMS). So these requirements can be a barrier to receiving this therapy for many patients, not just for Black patients.

However, based on years of favorable outcomes with CAR T-cell immunotherapies, recently the FDA issued an amendment to REMS reducing the duration of close-proximity monitoring from 4 weeks to 2 weeks.⁷ This change is expected to make CAR T-cell therapy more accessible to a greater number of patients.

One of the reasons we wanted to conduct this study was to better understand why we are not able to treat all of the patients who are referred for CAR T-cell therapy. The denominator for our study was patients who were able to enter into our system, but we know that there are many more who don’t even get a chance to come to a treatment center for this care, which is a bigger problem. But even among the patients we do see, there is a good proportion that do not get to receive CAR T-cell therapy.

We want to overcome whatever barriers are prohibiting patients from accessing this care because the side-effect profiles are improving and the products are becoming more effective. We are also hoping to remove some of the restrictions, including requiring outpatient care for the first 28 days posttreatment. Removing the barriers to CAR T-cell therapy and broadening access to a wider group of patients is a big goal for us.

CAR T-cell Therapy vs Stem Cell Transplantation

Does CAR T-cell therapy have the potential to replace autologous stem cell transplantation in the treatment of hematologic malignancies?

There have been head-to-head clinical trials investigating the benefit of autologous stem cell transplantation vs CAR T-cell therapy in patients with lymphoma, and CAR T-cell therapy is now offered ahead of autologous stem cell transplant in that cancer in some situations.⁸ And randomized studies are underway evaluating that question in patients with multiple myeloma.

We are hopeful and optimistic that even though the data evaluating CAR T-cell therapy vs stem cell transplantation is not completed, the evidence so far is showing that CAR T-cell therapy is beneficial to patients with hematologic cancers in the earlier disease setting.

Building on Progress to Benefit More Patients

Your coauthor on the study, Miguel-Angel Perales, MD, Chief of the Adult Bone Marrow Transplantation Service at MSK, has formed an international coalition called CAR T Vision, (https://cartvision.com) with the goal of doubling access to CAR T-cell therapy to eligible patients by 2030. Please talk about how the coalition plans to accomplish that goal.

Our vision is not to supplant ongoing initiatives by other organizations working in the CAR T-cell therapy space, but rather to build on the progress being made in this treatment. We know that not enough patients are benefiting from the therapy. Part of our vision is to see how treating institutions can remove barriers, including economic barriers by developing innovative financing approaches to help patients manage the costs of treatment and follow-up care.

We will reach out to treatment centers, policymakers, health-system leaders, payors, providers, and industry to expand access to CAR T-cell therapy, so more patients can receive this treatment, and also stay within their local communities while undergoing care. It may still be necessary for patients to receive this therapy in an accredited treatment center, but, hopefully, by partnering with physicians in the community setting, more patients will be able to receive their post-CAR T-cell therapy close to home without compromising their safety.

DISCLOSURE: Dr. Park receives consulting fees from Affyimmune Therapeutics, Allogene Therapeutics, Amgen, Artiva Biotherapeutics, Ascentage, Autolus, Beigene, Bright Pharmaceutical Services, Inc., Caribou Bioscience, Curocell, Kite, Iovance, Jazz Pharmaceuticals, Pfizer, Servier, Sobi, and Takeda.

REFERENCES

1. Zhang Z, Zhu L, Zhang H, et al: CAR T-cell therapy in hematological malignancies: current opportunities and challenges. Front Immunol 13:927153, 2022.
2. Valtis YK, Chin K-K, Nemirovsky D, et al: Barriers to chimeric antigen receptor T-cell therapy. JAMA Oncol 11(7):781-784, 2025.
3. Arnold KD, Ong KL, Ravi G, et al: Anthropometric traits and risk of multiple myeloma: differences by race, sex, and diagnostic clinical features. Br J Cancer 131(2):312-324, 2024.
4. Sharma P, Lin X, Xu Z, et al: FDA approval summary: idecabtagene vicleucel for the treatment of triple-class-expose, relapsed or refractory multiple myeloma. Clin Cancer Res 31(16):3362-3367, 2025.
5. Serani S: FA approves cilta-cel for earlier lines of R/R multiple myeloma. Targeted Oncology, April 6, 2024. Available at www.targetedonc.com/view/fda-approves-sbla-of-cilta-cel-for-earlier-lines-of-r-r-multiple-myeloma. Accessed November 18, 2025.
6. Cook JM: Racial disparities in multiple myeloma and access to stem cell transplantation. Blood Cancer J 14(1):120, 2024.
7. United States Food and Drug Administration: FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T-cell Immunotherapies. June 27, 2025. Available at www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor. Accessed November 18, 2025.
8. Locke FL, Miklos DB, Jacobson CA, et al: Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med 386:640-654, 2021.