CAR T Trial for Recurrent Ovarian Cancer Advances to 4th Cohort

Anixa Biosciences has announced the dosing of the first patient in the fourth cohort of its ongoing phase 1 clinical trial (NCT05316129) evaluating a novel chimeric antigen receptor (CAR) T-cell therapy for recurrent ovarian cancer.¹

The study, conducted in partnership with Moffitt Cancer Center under principal investigator Robert Wenham, MD, MS, FACOG, FACS, marks a critical advancement in assessing the safety and therapeutic potential of Anixa’s follicle-stimulating hormone receptor (FSHR)-targeted CAR T platform.

This announcement follows a successful third cohort, in which no dose-limiting toxicities were observed. The fourth cohort now is receiving a significantly escalated dose of 3 million CAR-positive T cells per kilogram, a 30-fold increase from the starting dose, continuing the structured dose-escalation design of the trial.

The therapy, referred to as FSHCER T cells, is genetically engineered to target FSHR. FSHR is selectively expressed on ovarian epithelium, tumor vasculature, and certain ovarian cancer cells, but is absent from most healthy tissues, offering a potentially tumor-specific therapeutic target.

This first-in-human trial includes adult patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer who have received at least 2 prior lines of treatment and have exhausted standard therapeutic options.

Trial Design and Objectives

This phase 1 study is evaluating the safety, maximum tolerated dose, pharmacodynamics, and preliminary efficacy of FSHCER T cells administered via intravenous (IV) or intraperitoneal (IP) routes.² Patients are receiving a single infusion at assigned dose levels ranging from 1 x 10⁵ to 1 x 10⁷ CAR T cells/kg, with or without conditioning chemotherapy. Dosing arms are mirrored for both IV and IP delivery, allowing for route-specific evaluation.

Enrollment is open to patients aged 18 years and older with a confirmed diagnosis of invasive epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with measurable or detectable disease, platinum-resistant or refractory status, and adequate organ function. Additional stratification includes consideration of prior therapies such as PARP inhibitors, MEK inhibitors, and folate receptor-alpha–targeted agents, depending on tumor histology. Further, patients must have an ECOG performance status of 2 or better or a Karnofsky performance status score of ≥60% and a life expectancy of at least 3 months.

The primary end point is to determine the maximum tolerated dose of FSHCER T cells, and secondary end points are duration of response, duration of stable disease, and overall survival.

Importantly, unlike many current CAR T targets that risk off-tumor activity, FSHR presents a promising therapeutic window with minimal anticipated collateral toxicity.

Implications for Oncology Practice

If successful, Anixa’s FSHCER T-cell therapy may offer a new class of highly specific, immune-based treatments for patients with recurrent ovarian cancer. This therapy's tumor-specific targeting and preliminary safety profile may enable broader outpatient use and reduced systemic toxicity, a critical consideration in solid tumor CAR T development.

The ongoing study is poised to not only inform dose optimization and safety but may also offer early signals of efficacy for a uniquely challenging disease.

REFERENCES:

1. Anixa Biosciences initiates dosing in fourth cohort in its ovarian cancer CAR-T clinical trial. News release. Anixa Biosciences Inc. June 23, 2025. Accessed June 23, 2025. https://tinyurl.com/t693xbru

2. Infusion of autologous T cells engineered to target FSH receptor in recurrent ovarian cancer. ClinicalTrials.gov. Updated May 21, 2025. Accessed June 23, 2025. https://clinicaltrials.gov/study/NCT05316129