HIV Patients Face Reduced Access to CAR-T Cancer Trials

A cross-sectional study, recently highlighted by the European Medical Journal (EMJ), reveals that access to CAR-T clinical trials for non-Hodgkin lymphoma remains significantly lower for people living with HIV (PWH) compared to the general population. The study, which analyzed actively recruiting adult CAR-T clinical trials for non-Hodgkin lymphoma in the contiguous United States as of May 2025, identified notable disparities in both geographic availability and the travel burden faced by PWH seeking these advanced treatments. CAR-T (Chimeric Antigen Receptor T-cell) therapy is a groundbreaking form of immunotherapy that has revolutionized the treatment landscape for certain blood cancers, including various types of non-Hodgkin lymphoma, acute lymphoblastic leukemia, and multiple myeloma. It involves extracting a patient's own T-cells, genetically engineering them in a laboratory to express chimeric antigen receptors (CARs) that can recognize specific proteins on cancer cells, multiplying these modified cells, and then re-infusing them into the patient. These 'supercharged' CAR-T cells then actively seek out and destroy cancer cells. The EMJ article, based on research published in *JAMA Network Open*, found that out of 254 eligible CAR-T clinical trials reviewed, only 80 met the specific inclusion criteria for analysis. Of these 80 trials, a mere 11 (13.8%) explicitly included PWH, while a substantial 58 (72.5%) explicitly excluded them. Another 11 (13.8%) did not specify HIV status in their eligibility criteria. This stark difference in inclusion policies directly translates to unequal access. One of the most significant findings of the study was the increased travel burden for PWH. The median population-weighted travel time for PWH to reach an HIV-inclusive CAR-T clinical trial site was 1.15 hours, considerably longer than the 0.84 hours for trials excluding PWH and 0.73 hours for the general trial population. Furthermore, access within a one-hour travel radius was substantially lower for HIV-inclusive studies (46.07%) compared to HIV-exclusive studies (55.27%). These disparities were most pronounced in the Southern United States, a region with a higher prevalence of HIV, where the median travel time to an HIV-inclusive trial was 1.70 hours, compared to 0.92 hours for HIV-exclusive studies. The historical exclusion of PWH from intensive cancer therapies, including clinical trials for novel treatments like CAR-T, has largely stemmed from concerns about their immune status, susceptibility to infections, and potential interactions with antiretroviral therapy (ART). However, significant advancements in ART have transformed HIV into a manageable chronic condition, with many PWH achieving undetectable viral loads and healthy immune function. Despite these medical advancements, outdated perceptions and guidelines often persist, leading to continued exclusion. Credible sources such as the American Society of Hematology (ASH) have presented study results demonstrating acceptable safety and effectiveness of CAR-T therapy for HIV-positive individuals with lymphoma, with outcomes comparable to those observed in HIV-negative patients. Experts argue that HIV infection should be viewed as a comorbidity, like any other, rather than a blanket exclusion criterion, especially for those with well-controlled disease. This issue of treatment disparity extends beyond CAR-T trials. The National Cancer Institute (NCI) has reported that PWH historically experience worse survival after a cancer diagnosis due to inequities in receiving cancer treatment. Although some disparities for certain cancers have declined over time, they persist for diffuse large B-cell lymphoma (a target for CAR-T therapy) and other cancers. The global relevance of this news is significant, including for an audience in India. While the specific study was conducted in the US, the underlying challenges of access to advanced medical treatments and the inclusion of vulnerable populations in clinical trials are universal. India has made remarkable strides in making CAR-T therapy more accessible. India's Central Drugs Standard Control Organization (CDSCO) approved the country's first indigenous CAR-T cell therapy, NexCAR19, in October 2023. This was followed by the approval of a second indigenous CAR-T therapy, varnimcabtagene autoleucel (var-cel), in January 2025. These indigenous therapies are significantly more affordable, costing around ₹30-50 lakhs (approximately $30,000-$60,000 USD) compared to ₹3-4 crore (approximately $400,000-$475,000 USD) for imported products. The availability of these therapies at select tertiary cancer centers in major Indian cities represents a major step towards broader access, although the inclusion criteria for PWH in these trials and treatments within India would still be a critical area to monitor. Beyond cancer treatment, CAR-T cell therapy is also being actively investigated as a promising approach for achieving a functional cure for HIV infection itself, by genetically modifying T-cells to target and eliminate HIV-infected cells. This ongoing research underscores the evolving understanding of HIV and the potential for CAR-T technology to address significant medical challenges for PWH from multiple angles. In conclusion, the EMJ article accurately highlights a critical barrier to equitable access for PWH in CAR-T clinical trials for non-Hodgkin lymphoma. Addressing these disparities requires a re-evaluation of exclusion criteria, increased awareness among clinicians, and targeted efforts to expand trial access, especially in regions with high HIV prevalence. The global medical community, including India, must work towards ensuring that all patients, regardless of HIV status, have fair opportunities to benefit from life-saving advanced therapies.

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