Media coverage:
A Single Infusion Could Suppress H.I.V. for Years, Study Suggests – Apoorva Mandavilli, New York Times, May 11, 2026
Small study shows one-time cell therapy can control HIV infection – by Deena Beasley, Reuters, May 11, 2026
Small study hints that revving up immune cells might help fight HIV – Lauran Neergaard, Associated Press, May 12, 2026
Original source(s):
CAR-T for HIV – Steve Deeks, MD, American Society for Cell & Gene Therapy annual meeting, Boston, May 12, 2026
TAG’s commentary:
A story by Apoorva Mandavilli in the May 11, 2026 edition of the New York Times reported on potentially encouraging — but very limited — HIV cure research findings that were presented by Dr. Steven Deeks at the American Society of Gene & Cell Therapy (ASCGT) annual meeting in Boston on May 12. The results derive from an ongoing clinical trial of a type of gene therapy called chimeric antigen receptor (CAR) T cells in people with HIV. A media story appearing prior to the presentation isn’t ideal, because it publicly releases scientific information that few other people have had a chance to review.
Background
CAR-T cells are immune cells that have been genetically modified in the laboratory to endow them with receptors capable of recognizing a specific target of interest. Multiple CAR-T cell approaches targeting cancers have demonstrated efficacy and received FDA approval, many trials remain ongoing with news recently emerging that an experimental CAR-T cell therapy successfully treated actor Sam Neill’s cancer (stage three angioimmunoblastic T-cell lymphoma). CAR-T cells have also been designed to target HIV, with very early technologies tested as far back as the 1990s (Dr. Deeks was involved in this prior research).
The clinical trial presented at the ASCGT meeting is testing a “duoCAR-T cell” strategy developed by the company Caring Cross: T cells are genetically modified to shield against HIV infection and equip them with receptors targeting two conserved (less prone to mutate) parts of the HIV Envelope protein. The duoCAR-T cells have previously been shown to kill HIV-infected cells and suppress viral load in humanized mouse models, and the research that led to the clinical trial is extensively reviewed in an open access paper published in JCI Insight in 2022. For human use, T cells are extracted from study participants, genetically altered in the laboratory, and then reinfused at specific doses.
Study Results
The current news stories focus on two participants in the trial who’d been on antiretroviral therapy (ART) since very soon after HIV acquisition (they’d started at Fiebig stage 4, ~17-20 days after exposure).
As part of the study protocol, both received a single infusion of duoCAR-T cells and immediately underwent an analytical ART interruption (ATI). The duoCAR-T cell dose was 3×105 or 300,000 cells, the lowest used in the study. The infusion was administered after a “conditioning” dose of cyclophosphamide (1 gm/m2) intended to transiently suppress the immune system and make space for the duoCAR-T cells.
The two individuals have now controlled HIV viral load off ART for over 92 weeks (~1.7 years) and 44 weeks, respectively. Preliminary analysis of gut biopsy samples indicates low or barely detectable amounts of HIV Gag DNA in gut tissue (measured as a proxy for the HIV reservoir).
One other study participant maintained HIV viral load suppression for around seven weeks before rebound, and another experienced what’s described as “partial” control at around 1,000 copies/mL for about 12 weeks before a further increase prompted ART reinitiation. These latter two individuals received an infusion of a million duoCAR-T cells, the highest dose so far administered in the study.
The researchers were also able to measure levels of the infused duoCAR-T cells, which were initially detectable but waned to low or undetectable after several weeks. The duoCAR-T cells couldn’t be detected in the gut tissue samples from the two participants with prolonged viral load suppression.
Deeks reported data for a total of eleven study participants (all cisgender men), nine of whom underwent ATI. The two cases of extended viral load control therefore represent 22% of the participants who interrupted ART. Six of the nine people who underwent ATI had started ART much later than the controllers, during chronic HIV infection.
An important caveat is that it’s known that a small proportion of people who start ART early can display control of HIV viral load for an extended period when ART is interrupted, in the absence of other interventions. The HIV suppression in the two duoCAR-T cell recipients appears unusually strict, however, and further follow up (and possibly additional tissue sampling) should shed light on comparability with other reported cases of posttreatment control.
The hope is that the duoCAR-T cells were able to tip the balance in favor of the immune system when the amount of HIV present was relatively low due to the participants having started ART so early. If borne out, this would suggest that strategies capable of reducing the size of the HIV reservoir could set the stage for CAR-T cells to be effective.
Dr. Deeks reported that the duoCAR-T cell infusions were safe, with none of the side effects that have been seen in the setting of cancers (e.g. cytokine release syndrome, neurotoxicity). The likely explanation is that the burden of cancer in the body is typically much greater than the amount of virus in people with HIV, and these adverse events are driven by CAR-T cells reacting to their target.
There was a serious side effect associated with administration of the cyclophosphamide conditioning: grade 4 neutropenia and lymphopenia in one participant, detected after around two weeks, which is slowly resolving. The ATI led to expected transient drops in CD4 T cell counts, but there were no cases of acute retroviral syndrome (e.g. fever, malaise) or sexual transmission of HIV to partners.
The take-home message is that the CAR-T cell gene therapy approach that has shown success against cancers may also have promise in HIV, but the results are very preliminary with further research and follow up needed. The New York Times and Associated Press headlines stating that the data “suggests” or “hints” that CAR-T cells could be beneficial are appropriately cautious.
CAR-T cell delivery is currently cumbersome and costly due to the need to extract, modify, and reinfuse cells. There are ongoing efforts to address this limitation by developing technologies capable of genetically modifying T cells in the body, obviating the need to extract and reinfuse.
Caring Cross
The company Caring Cross is notable and unusual for their dedication to working to improve global access to gene therapies, and their community advisory board (CAB) includes several highly respected HIV advocates. More information about the company can be found on their website and in a presentation by Dr. Boro Dropulić for a community webinar sponsored by the Martin Delaney Collaboratories CABs in 2023 (posted on Michael Louella’s defeatHIV YouTube channel). Drs. Rimas Orentas and Kim Anthony-Gonda have also given in-depth talks about the duoCAR-T cell technology on past webinars: as part of a gene therapy series and at the 2021 Pre-CROI Community HIV Cure Research Workshop, respectively.
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