WATERTOWN, Massachusetts, USA & DRESDEN, Germany, June 2, 2026
AvenCell Therapeutics has announced that it will present results from the completed Phase 1a portion of the RevSTAR-123 study evaluating AVC-201, its investigational switchable allogeneic CD123 CAR-T therapy, in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) and minimal residual disease (MRD)-positive AML. The data have been selected for a prestigious late-breaking oral presentation in the plenary session at the 2026 European Hematology Association (EHA) Congress, highlighting growing interest in next-generation cell therapies designed to address significant unmet needs in hematologic malignancies. As one of the first clinical evaluations of a switchable allogeneic CAR-T platform targeting CD123-positive AML, the presentation is expected to provide important insights into the safety, clinical activity, and future development potential of this innovative off-the-shelf cellular immunotherapy approach.
First-in-Class Switchable CAR-T Strategy Targets AML
AVC-201 is based on AvenCell’s proprietary RevCAR platform, a novel technology designed to overcome some of the limitations associated with conventional autologous CAR-T therapies. Unlike traditional CAR-T treatments that require individualized manufacturing from a patient’s own cells, AVC-201 is an allogeneic, off-the-shelf CAR-T therapy that can potentially be administered more rapidly and efficiently. The platform incorporates a unique switchable mechanism using antigen-specific target modules, enabling pharmacologic control of CAR-T cell activity.
This approach is designed to provide physicians with greater flexibility in managing treatment intensity and potentially improving safety while maintaining anti-cancer effectiveness. The therapy specifically targets CD123, a protein commonly expressed on AML cells and leukemic stem cells, making it an attractive target for cellular immunotherapy development in patients with difficult-to-treat disease.
RevSTAR-123 Study Advances Next-Generation Cell Therapy Development
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The RevSTAR-123 trial enrolled patients with CD123-positive relapsed/refractory AML and MRD-positive AML, populations that often face limited treatment options and poor long-term outcomes. Relapsed AML remains one of the most challenging blood cancers to treat, with many patients experiencing resistance to standard therapies and requiring novel therapeutic approaches. The completion of the Phase 1a portion of the study marks an important milestone for AvenCell as it advances the clinical evaluation of AVC-201.
Selection of the data for presentation during the EHA plenary session underscores the scientific significance of the findings and the potential impact of the technology within the hematology community. While detailed efficacy and safety results will be disclosed during the congress presentation, the inclusion as a late-breaking abstract reflects the importance of the data and growing interest in innovative cell therapy strategies capable of addressing persistent challenges in AML treatment.
Expanding the Future of Off-the-Shelf Cellular Immunotherapy
The development of allogeneic CAR-T therapies represents one of the most active areas of innovation in oncology. Researchers are increasingly focused on creating cell therapies that combine the potent anti-cancer activity of CAR-T technology with the convenience and scalability of readily available donor-derived products. AvenCell’s RevCAR platform is designed to support this vision by enabling controllable CAR-T cell activity through antigen-specific targeting modules, potentially improving both treatment accessibility and clinical management. If successful, AVC-201 could help establish a new generation of programmable cellular immunotherapies capable of being tailored to individual patient needs while reducing manufacturing complexity.
The upcoming EHA 2026 presentation will provide clinicians, researchers, and investors with the first detailed look at the Phase 1a findings and may offer important evidence supporting continued development of switchable allogeneic CAR-T therapies for AML. As the field of cell therapy continues to evolve, AvenCell’s innovative platform could play a significant role in shaping future treatment paradigms for hematologic cancers.
Source: AvenCell Therapeutics press release
