Azalea Shows In Vivo CAR T Clears Leukemia in Mice

Berkeley-based Azalea Therapeutics presented preclinical data on its in vivo TRAC-CAR T cell platform at SITC 2026 in Phoenix.

Updated on Nov. 6, 2026 in Biotech

Azalea Shows In Vivo CAR T Clears Leukemia in Mice

Azalea Therapeutics presented new preclinical data on its in vivo TRAC-CAR T cell platform at the SITC 2026 Annual Meeting. The platform achieved complete clearance of CD19-positive leukemia in mice at active dose levels following a single intravenous administration.

Why it matters

The data suggest CAR T cells can be generated directly inside the body rather than manufactured ex vivo, a development aimed at producing durable and regulated therapies. The work is positioned for potential clinical translation, though the results described are preclinical.

Preclinical results show 99% of filtered sequencing reads mapped to the intended TRAC locus, and CAR T cells reached up to 41% of peripheral T cells in non-human primates. Tumor control was maintained after a secondary challenge about 60 days post-treatment in select mouse groups, but human safety and durability data are not yet reported.

The players

Azalea Therapeutics

A biotechnology company headquartered in Berkeley, California, developing in vivo CAR T cell therapies.

The details

A single intravenous administration of enveloped delivery vehicles and adeno-associated viruses generated TRAC-CAR T cells in humanized mouse models and immunocompetent non-human primates. The approach inserts the CAR gene at the TRAC locus so expression is controlled by the endogenous T cell promoter, and the modular platform produced dual CD19/CD20-targeted cells.

Timeline

  1. November 4-8, 2026: SITC 2026 Annual Meeting in Phoenix, Arizona.

  2. Friday, November 6, 2026, 9:00 am ET: ePoster available on the SITC virtual meeting platform.

  3. Saturday, November 7, 2026: Presentation of abstract 950 by Connor Tsuchida.

Field Context

Current approved CAR T therapies rely on ex vivo manufacturing, where a patient's T cells are collected, engineered, expanded and reinfused. Azalea's in vivo TRAC-CAR platform instead attempts to generate CAR T cells directly inside the body, departing from that established ex vivo model.

The work remains preclinical, so it does not yet change access to treatment for patients. Readers should watch for human clinical trial announcements that would indicate whether in vivo CAR T therapies become available.

The takeaway

In vivo CAR T approaches aim to remove the need for ex vivo cell manufacturing, which could simplify treatment if the preclinical results hold in humans. Readers should treat these findings as early-stage evidence rather than an available therapy.

Further reading

Explore more California Biotech developments shaping the state's life sciences sector.

Source note: This article includes information reported by The Manila times.