Caring Cross Announces Dosing of First Participant in Anti-HIV DuoCAR-T Cell Therapy Phase 1/2a Clinical Trial

Anti-HIV DuoCAR-T cell therapy offers potential to eliminate HIV-infected cells and suppresses HIV infection long-term in the body

Groundbreaking clinical trial being conducted in collaboration with University of California, San Francisco, University of California, Davis, and the California Institute for Regenerative Medicine (CIRM)

GAITHERSBURG, Md., Oct. 11, 2022 /PRNewswire/ -- Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, announced the dosing of the first participant in a Phase 1/2a clinical trial evaluating the organization's Anti-HIV DuoCAR-T cell therapy. Caring Cross has designed its Anti-HIV DuoCAR-T cell therapy to potentially eliminate HIV-infected cells and suppresses HIV infection long-term in the body after a single infusion. 

Initiation of the Phase 1/2a trial represents the first-in-human clinical study investigating a dual chimeric antigen receptor (duoCAR)-T cell therapy for the treatment of HIV. The Phase 1/2a clinical trial, which is currently enrolling participants at the University of California, Davis (UC Davis) and is being led by Steven Deeks, M.D., of the University of California, San Francisco (UC San Francisco) and Mehrdad Abedi, M.D., of the University of California, Davis, is designed as a three-cohort (3+3), open-label dose escalating study to evaluate the safety and tolerability of varying single dose regimens of the Anti-HIV DuoCAR-T cell therapy.  The primary endpoints for the Phase 1/2a trial are safety and tolerability and to identify the optimal dose of the Anti-HIV DuoCAR-T cell therapy for ongoing clinical development.  Additional details on the Phase 1/2a clinical trial, including enrollment information, may be found on ClinicalTrials.gov, identifier: NCT04648046.

"We have reached an important milestone with the dosing of the first participant in the Phase 1/2a clinical trial evaluating a potentially groundbreaking anti-HIV duoCAR-T cell therapy. Our primary goal for this clinical trial is to establish the safety of this promising therapeutic approach.  We are happy to be collaborating with UC Davis, Caring Cross, Case Western Reserve University Hospitals and CIRM on this clinical trial," said Dr. Deeks, professor of medicine at UC San Francisco who has been engaged in HIV research and clinical care since 1993.

Dr. Abedi, Professor of Medicine at UC Davis, added: "The first participant was dosed with anti-HIV duoCAR-T cells at the UC Davis medical center in mid-August. There were no adverse events observed that were related to the product and the participant is doing fine."

The Anti-HIV DuoCAR-T therapy was developed by members of Caring Cross as a potentially curative therapy for HIV. Pre-clinical research investigating the Anti-HIV DuoCAR-T cell therapeutic candidate has demonstrated an ability to potently suppress HIV and eliminate HIV-expressing cells in vitro and in animal models.  Research detailing this capability was published in a 2019 paper in Science Translational Medicine, "Multispecific anti-HIV duoCAR-T cells display broad in vitro antiviral activity and potent in vivo elimination of HIV-infected cells in a humanized mouse model."

A new study, spearheaded by lead-author Kim Anthony-Gonda, Ph.D., Director of Cell and Gene Therapy at Caring Cross has been recently accepted for publication in the Journal of Clinical Investigation (JCI) Insight, highlighting results from an IND-enabling study examining whether the Anti-HIV DuoCAR-T cell technology can travel to the spleen of humanized mice with active HIV infection and inhibit replication of the virus. Data from the study concluded that intravenously administered Anti-HIV DuoCAR-T cells travelled from the peripheral blood to the spleen and demonstrated potent and durable suppression of HIV replication after a single injection of Anti-HIV DuoCAR-T cells.

Boro Dropulić, Ph.D., Co-founder and Executive Director of Caring Cross, said: "We are delighted to have dosed the first participant in this first-in-human clinical trial using CAR-T cells that kill HIV-infected cells and simultaneously protect CD4 T cells from HIV infection.  We look forward to continuing the trial with the goal of establishing the safety and efficacy of this therapeutic approach. We are honored to be collaborating with UC San Francisco, UC Davis and Case Western Reserve University Hospitals on this clinical trial and we are grateful to the California Institute for Regenerative Medicine for their support."

"We are happy to be supporting this important work. We look forward to seeing the data as the participants are enrolled in the trial," said Sohel Talib, Ph.D., Director of Therapeutic Development at CIRM.

Approximately 38 million people are living with HIV around the world and over half of them receive antiretroviral therapy. Despite the progress made in treatment, an estimated 1.5 million new cases and 650,000 people died from AIDS-related illnesses worldwide in 2021, according to UNAIDS.ⁱ

For inquiries about the Phase 1/2a clinical trial:

Trial Site: University of California, Davis
Investigators: Paolo Troia-Cancio, MD and Mehrdad Abedi, MD
Study Coordinator: Christina Dyer, CCRP
Phone: 916-703-3110 or 916-703-9118
Email: [email protected]

Trial Site: University of California, San Francisco
Investigator: Steven G. Deeks, MD
Study Coordinator:  Rebecca Hoh, MS, RD
Phone: (415) 476-4082 x 139
Email: [email protected]

Caring Cross is a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and ensuring access to cures for all patients, everywhere. To enable its mission, Caring Cross is developing technologies and therapeutic candidates to improve the accessibility, affordability and applicability of CAR-T technology and stem cell gene therapy. These opportunities include developing and implementing affordable solutions for the manufacture of CAR-T cells, advancing a decentralized, place-of-care cell manufacturing model, and developing its first therapeutic candidate, an Anti-HIV DuoCAR-T Cell Therapy designed to suppress HIV replication and eliminate HIV-expressing cells in people with HIV. A stem cell gene therapy for Sickle Cell Disease and Beta-Thalassemia is also in development. For more information on Caring Cross visit https://caringcross.org/.

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ⁱ UNAIDS https://www.unaids.org/en/resources/fact-sheet

SOURCE Caring Cross