Anixa hits top dose in ovarian cancer CAR T trial

By Elena MacLeod · September 28, 2026, 5:48 PM · 3 mins read

Anixa Biosciences and Moffitt Cancer Center have now treated a patient at the highest dose in their ovarian cancer CAR T cell trial. Early safety and survival results look promising.

Five women with recurring ovarian cancer have now lived more than a year after getting Anixa Biosciences’ experimental CAR T cell therapy. For this group, that’s rare. The latest step: the first patient has now received the highest dose yet in the Phase 1 trial of liraltagene autoleucel (lira-cel). No dose-limiting side effects have turned up so far.

This move to the fifth group is a big moment for a treatment aimed at a cancer with few good options. The patient got 1×10⁷ CAR-positive cells per kilogram after lymphodepletion. That’s the strongest dose in the study so far. Earlier groups, including the 3x10⁶/kg dose, also had no dose-limiting side effects. That’s unusual for cell therapy in solid tumors. A Morningstar company report says Anixa is running this program with Moffitt Cancer Center. Lira-cel is now a main part of Anixa’s ovarian cancer immunotherapy pipeline.

The CER-T therapy targets the follicle-stimulating hormone receptor (FSHR), which is highly expressed on ovarian cancer cells but has limited presence in healthy tissues.

The trial, listed as NCT05316129, is testing a chimeric endocrine receptor-T cell (CER-T) therapy. It’s built to target the follicle-stimulating hormone receptor (FSHR). This marker shows up on ovarian cancer cells but is mostly missing from healthy tissue. The main goal is to check safety and tolerability. But survival numbers are drawing notice. As of July 6, 2026, the five patients have survived about 28, 20, 17, 17, and 13 months after treatment.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, said the lack of dose-limiting side effects across five dose levels is a real milestone. The survival data gives hope to patients who usually face poor odds. Anixa’s pipeline includes this immunotherapy with Moffitt Cancer Center and vaccines licensed from Cleveland Clinic. The company’s breast cancer vaccine platform is covered by a Korean patent through 2040. In an earlier Phase 1 trial, 74% of participants showed protocol-defined immune responses.

CAR T cell therapy has changed blood cancer treatment. But using it for solid tumors like ovarian cancer is still tough. Recent reported efforts in next-generation CAR T for other hard-to-treat cancers show how urgent and competitive this field is.

Recent market updates indicate that Anixa has already dosed the first patient in the highest cohort and continues to position lira-cel as a central asset, with no new safety limitations publicly reported as of September.

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No dose-limiting side effects have shown up at the highest dose. Several patients have now lived more than a year. Anixa and Moffitt are pushing the limits of cell therapy in ovarian cancer. The big questions: Will these responses last? Will severe side effects stay away? If so, this CER-T approach could finally bring a breakthrough for patients left behind by standard treatments. For now, the trial’s progress offers a rare bit of hope in a field where every extra month matters.

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Elena MacLeod

Elena MacLeod is Clinical Biotechnology Editor at GenoMethods, covering CAR-T, engineered cell therapies, gene therapy, clinical trials, cancer immunology and regulatory developments. Her evidence-first reporting focuses on trial design, patient populations, safety, efficacy, response durability and the limitations that determine how early clinical results should be interpreted.