Allogene Therapeutics (NASDAQ:ALLO) said new pre-clinical data for its investigational CAR-T therapy ALLO-329 have been published in Nature Communications, highlighting a dual-targeting approach aimed at treating autoimmune diseases.
ALLO-329 is an allogeneic, off-the-shelf CAR-T candidate designed to target both CD19-positive B cells and CD70-positive activated T cells, two key drivers of autoimmune conditions. The data showed the therapy maintained strong anti-CD19 activity while avoiding immune rejection and promoting CAR-T cell expansion.
The dual-targeting design also demonstrated improved effectiveness in tumor models with antigen loss and reduced antibody levels in autoimmune disease models, suggesting potential for broader therapeutic impact.
The findings further support the company’s Dagger® technology, which is intended to enhance CAR-T cell persistence and potentially reduce or eliminate the need for traditional lymphodepletion, a key barrier in current treatments.
“The preclinical data published in Nature Communications highlight the potential of ALLO-329’s dual-targeting approach to address both B- and T-cell drivers of autoimmune disease,” said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. “By combining precision targeting with an off-the-shelf platform, we believe ALLO-329 has the potential to deliver a more complete and scalable treatment approach without the need for intensive lymphodepletion. We are excited to advance this program and explore its potential across a range of autoimmune diseases.”
Allogene is currently evaluating ALLO-329 in its Phase 1 RESOLUTION trial, which is enrolling patients with conditions including lupus, scleroderma and inflammatory myositis. The study is testing multiple dose levels, starting at 20 million CAR-T cells, across cohorts receiving reduced or no lymphodepletion.
Initial data from the first cohort are expected in June 2026, with further updates anticipated later in the year.
ALLO-329 has already received Fast Track designation from the U.S. Food and Drug Administration for multiple autoimmune indications, including lupus, myositis and scleroderma.
If successful, the therapy could open a significant new market for cell therapies, particularly given its scalable manufacturing model and potential for broader accessibility compared with existing approaches.