Allogene Therapeutics Announces Nature Communications Publication Highlighting Pre-Clinical Data for ALLO-329, a Next Generation Dual-Targeted CD19/CD70 Allogeneic CAR T for Autoimmune Diseases
Rhea-AI Summary
Allogene Therapeutics (Nasdaq: ALLO) announced pre-clinical data for ALLO-329, a dual-targeted CD19/CD70 allogeneic CAR T, published in Nature Communications.
Preclinical results show the CD70 CAR may protect against immune rejection, enabling robust CAR T expansion and persistence and suppressing autoantibody production in SLE models. A Phase 1 RESOLUTION dose-escalation trial is enrolling; initial human translational data from the first 20M-cell dose cohort are expected in June 2026.
AI-generated analysis. Not financial advice.
Positive
- Dual-targeting CD19/CD70 showed immune-rejection protection in preclinical models
- Robust CAR T expansion and persistence observed in preclinical studies
- RESOLUTION Phase 1 actively enrolling with a low starting dose of 20 million CAR T cells
- Initial human data from first cohort expected in June 2026
- Three FDA Fast Track designations for lupus, myositis and scleroderma
Negative
- Efficacy limited to preclinical models; human clinical efficacy not yet demonstrated
- Primary clinical readouts and safety still pending; initial data expected June 2026
- Competitor programs use substantially higher doses (5–50x), raising comparative efficacy uncertainty
News Market Reaction – ALLO
On the day this news was published, ALLO declined 4.82%, reflecting a moderate negative market reaction. Argus tracked a peak move of +19.0% during that session. Argus tracked a trough of -11.7% from its starting point during tracking. Our momentum scanner triggered 33 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $40M from the company's valuation, bringing the market cap to $792.28M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ALLO fell 25.49% while close peers showed mixed moves (e.g., CADL up 4.08%, IVVD down 7.47%). Momentum scanner peers were split (IMMP up 155.02%, ACIU down 2.74%), reinforcing a stock-specific move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 10 | ALPHA3 update | Positive | +12.5% | Announcement of upcoming ALPHA3 interim futility analysis and investor call. |
| Jun 01 | ALLO-316 RCC data | Positive | +8.6% | Phase 1 TRAVERSE data showing responses in heavily pretreated RCC patients. |
| Feb 13 | Cema-cel JCO data | Positive | +44.7% | Publication of durable LBCL responses and high CR rates for cema-cel. |
| Nov 18 | ALLO-329 preclinical | Positive | -5.3% | Preclinical ALLO-329 autoimmune data with dual CD19/CD70 targeting at ACR. |
| Nov 07 | ALLO-316 RCC data | Positive | -0.9% | Positive Phase 1 ALLO-316 RCC data with RMAT designation for RCC. |
Clinical trial and preclinical updates have typically produced positive reactions, though two recent ALLO-316/ALLO-329 data events saw modest or negative moves despite constructive efficacy and safety signals.
Recent history for Allogene shows multiple clinically focused milestones. In Nov 2024, preclinical ALLO-329 autoimmune data at ACR highlighted dual CD19/CD70 targeting but saw a -5.29% move. Through 2025, positive ALLO-316 RCC Phase 1 data and cemacabtagene ansegedleucel (cema-cel) LBCL data, including a 58% ORR and 42% CR improving to 67%/58%, were met with strong gains, up to 44.68%. The Apr 10, 2026 ALPHA3 interim futility announcement also coincided with a 12.5% rise. Today’s Nature Communications ALLO-329 preclinical publication and RESOLUTION trial details extend this autoimmune program after earlier preclinical presentations.
Historical Comparison
Clinical-trial and preclinical updates for ALLO have averaged a 11.9% move. Today’s ALLO-329 autoimmune data and RESOLUTION trial details contrast with that history given the concurrent -25.49% decline.
ALLO-329 has progressed from preclinical ACR data in Nov 2024 to a peer-reviewed Nature Communications publication and active Phase 1 RESOLUTION enrollment across autoimmune indications, building on the company’s broader clinical CAR T experience.
Market Pulse Summary
This announcement details peer-reviewed preclinical ALLO-329 data in Nature Communications and outlines the Phase 1 RESOLUTION basket design, starting at 20 million CAR T cells with reduced or no lymphodepletion. It extends prior dual CD19/CD70 autoimmune work and builds on multiple FDA Fast Track designations. Investors may track execution against the June 2026 initial data goal, subsequent year-end update, and how dose, safety, and biomarker readouts compare with higher-dose autologous and allogeneic competitors.
Key Terms
allogeneic medical
car t medical
lymphodepletion medical
fast track regulatory
systemic lupus erythematosus medical
scleroderma medical
inflammatory myositis medical
biomarkers medical
AI-generated analysis. Not financial advice.
- 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
Christine.Cassiano@allogene.com
