One patient in Anixa Biosciences’ phase 1 trial has now gone three months without disease progression after treatment with the company’s FSHR-targeted CAR T cell therapy, liraltagene autoleucel (lira-cel). This is the first time stable disease has lasted this long in the study. The result came at the highest dose tested so far. No dose-limiting toxicities have been reported in any patient, according to recent independent updates.
This patient was part of the fifth dose group. She received 1 × 10⁷ CAR-positive cells per kilogram after lymphodepletion. After ninety days, her disease had not progressed. That’s a change from the usual pattern of rapid progression in this setting. Anixa reports that several patients in the trial have survived more than a year after treatment. One has lived past two years. The company’s update listed four patients with survival times of about 28, 19, 17, and 17 months after therapy. These numbers suggest some patients may get longer benefit, even after heavy prior treatment.
The phase 1 trial reached its highest tested dose of 1×10⁷ CAR-positive cells/kg in the fifth cohort, with a second patient treated at this level by late September 2026.
How the FSHR CAR T approach works
Lira-cel targets the follicle-stimulating hormone receptor (FSHR). This protein appears on ovarian cancer cells and on blood vessels in ovarian and other cancers. The therapy uses follicle-stimulating hormone to find and attack these cells. Most healthy tissues are spared. Doctors give the treatment directly into the peritoneal cavity, where ovarian cancer usually spreads. This method aims to boost the drug’s local effect.
The phase 1 trial is sponsored by Moffitt Cancer Center and Anixa. It’s the first time lira-cel is being tested in humans. The study is single-center and includes patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer. To join, patients must have platinum-refractory or platinum-resistant disease and have tried at least two chemotherapy regimens. The trial uses strict inclusion and exclusion rules. Doses of lira-cel are being increased stepwise, from 1 x 10^5 up to 1 x 10^7 CAR-positive cells. Both intravenous and intraperitoneal routes are being tested. The main goal is to find the maximum tolerated dose. Other measures include how long responses last, how long disease stays stable, and overall survival. A recent RTTNews report confirms that no dose-limiting toxicities have been seen in any group, even at the highest dose.
Early signals and ongoing questions
The trial’s main focus is safety. Still, seeing stable disease at the highest dose, with no dose-limiting toxicities, is a positive sign. Robert M. Wenham, MD, MS, the principal investigator at Moffitt Cancer Center, said, “This result, and the absence of dose-limiting toxicities observed thus far, is encouraging as we continue to treat patients in the current and future dose cohorts.” Anixa CEO Amit Kumar, PhD, also called the stable disease and longer survival in several patients “very encouraging” as the company tests higher doses.
The trial, registered as NCT05316129, is a first-in-human, single-center, dose-escalation study for patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer who have received at least two prior lines of chemotherapy.
Researchers are now running correlative studies to see how long CAR-positive cells last in patients and how durable their effect is. No timeline has been given for more data. The company has not reported any partial or complete responses on scans. The trial is small and still early, so it’s too soon to draw conclusions about how well the therapy works.
Ovarian cancer that comes back after treatment is hard to control. This case of stable disease stands out. The FSHR-targeted approach could have uses beyond ovarian cancer, but larger studies are needed. For now, the lack of dose-limiting toxicities and the first sign of disease control mark a real, if cautious, step forward for Anixa’s platform. Progress is slow. But it’s real. Other cell therapy trials, like those covered by Investing.com, have shown similar slow gains. The next phase for lira-cel will depend on whether these early safety and disease control signals can turn into longer-lasting and more meaningful results as the trial continues.
