- Study Highlights Dagger® Technology Showing that an Optimized CD70 CAR has the Potential to Protect Against Immune Rejection, Enabling Robust Expansion and Persistence of Allogeneic CAR T Cells in Pre-Clinical Models
- Dual CD19/CD70 CAR T Cells Rapidly Eliminated B and T Cells in Systemic Lupus Erythematosus (SLE) Models, Halting Autoantibody Production
- Phase 1 RESOLUTION Dose Escalation Rheumatology Basket Trial Actively Enrolling; Initial Data from First Dose Level Expected June 2026 with an Additional Clinical Update Planned for Year-End
- ALLO-329 Previously Received Three FDA Fast Track Designations for the Treatment of Adult Patients with Lupus, Myositis and Scleroderma
SOUTH SAN FRANCISCO, Calif., April 15, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today announced the publication of pre-clinical data for ALLO-329 in Nature Communications. ALLO-329 is an investigational allogeneic CAR T product developed specifically for autoimmune diseases.
The publication details the observed precision of ALLO-329 in targeting both CD19+ B cells and CD70+ activated T cells, which are implicated in a range of autoimmune diseases. These findings demonstrate a novel approach to enhance allogeneic CAR T cell activity and persistence in these settings, with a goal of reducing or eliminating significant cytotoxic lymphodepletion. Pre-clinical data show that allogeneic CD19 CAR T cells engineered with an anti-rejection CD70 CAR retain robust anti-CD19 activity, avoid rejection and promote CAR T cell expansion. This dual-targeting approach was also observed to improve therapeutic efficacy in tumor models of antigen loss and achieve suppression of antibody titers in an autoimmune disease model. Integrating both CARs into a single, off-the-shelf allogeneic product has the potential to offer a scalable, consistent manufacturing solution with the ability to expand clinical impact across hematologic malignancies and autoimmune diseases characterized by CD19 and CD70 expression.
These findings further validate the potential of the Company’s clinically proven Dagger® technology, designed to enhance CAR T cell expansion and persistence. In ALLO-329 for autoimmune disease, this approach is intended to enable robust expansion and persistence of allogeneic CAR T cells, while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion.
“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."
The Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis. The trial is evaluating multiple dose levels, beginning at 20 million CAR T cells, in two parallel cohorts: one receiving reduced lymphodepletion consisting of cyclophosphamide only and one receiving no lymphodepletion. For context, competing CAR-T programs in autoimmune disease are evaluating autologous doses 5-10x higher, while other allogeneic approaches use cell doses up to approximately 50x higher than those in the RESOLUTION trial.
Initial data from the first dosing cohort are expected in June 2026 and are expected to include translational data, including disease-related biomarkers, CAR T expansion, immune reconstitution, and early clinical outcomes. Assuming continued enrollment and follow-up, Allogene anticipates providing an additional clinical update later this year.
If successful, ALLO-329 could open one of the largest new markets in cell therapy, where scalable manufacturing, a favorable tolerability profile, and accessibility to treating physicians could become critical competitive differentiators.
About ALLO-329
ALLO-329 is a CD19/CD70 dual AlloCAR T investigational product being developed for the treatment of autoimmune diseases. In April 2025, the U.S. Food and Drug Administration granted three Fast Track Designations (FTD) to ALLO-329 for the treatment of adult patients with lupus, myositis, and scleroderma. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Dagger® technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications.
About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.
Cautionary Note on Forward-Looking Statements for Allogene
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “potential,” “explore,” “expect,” “anticipate,” “can,” “could,” “may,” “designed to,” “developing,” “will,” “advance,” “targets,” “scheduled,” “goal,” “empower,” “believe,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability for a dual-targeted CD19/CD70 allogeneic Car T to treat autoimmune diseases and its potential to offer a scalable, consistent manufacturing solutions with the ability to expand clinical impact across hematologic malignancies and autoimmune diseases characterized by CD19 and CD70 expression; the potential benefits of ALLO-329 and Allogene’s Dagger technology, including its potential to protect against rejection by the host immune system, drive or enhance CAR T cell expansion and persistence and reduce or eliminate the need for lymphodepletion; the preclinical data for ALLO-329 highlighting and further validating the potential of Allogene’s Dagger technology; ALLO-329’s ability to achieve its goal of reducing or eliminating significant cytotoxic lymphodepletion, thereby potentially offering a favorable tolerability profile; Allogene’s Phase 1 RESOLUTION trial, including the timing for data announcements and clinical updates; the ability for ALLO-329 to precisely target CD19+ B-cells and CD70+ activated T-cells to offer a more complete and scalable treatment option for patients with a range of autoimmune diseases; the ability for ALLO-329 to address both B-cell and T-cell dysfunction; the potential for ALLO-329 to open one of the largest new markets in cell therapy; and the potential for ALLO-329 to treat patients with systemic lupus erythematosus, scleroderma and inflammatory myopathies. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: results from pre-clinical studies may not be representative of results from clinical trials; Fast Track Designations may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval; our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the clinical validation of our Dagger technology in a separate clinical trial for our oncology program may not result in clinical validation when used in the treatment of autoimmune diseases; our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials, including initiation of clinical trials, or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; and the challenges with manufacturing of our product candidates to deliver readily available cell therapy on-demand, more reliably, and at greater scale to more patients. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factors” heading in its Annual Report on Form 10-K filed for the year ended December 31, 2025, filed with the Securities and Exchange Commission (SEC) on March 12, 2026, and other filings that Allogene may make from time to time with the SEC. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Dagger® is a trademark of Allogene Therapeutics, Inc.
ALLO-329 (CD19/CD70) in autoimmune disease uses CRISPR gene-editing technology.
Allogene Media/Investor Contact:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
[email protected]