Study of Novel CAR T in Ovarian Cancer Continues to Progress

Patient treatment and dose escalation continues to progress successfully with a novel follicle-stimulating hormone receptor (FSHR)–targeting CAR T-cell therapy being explored in a phase 1 trial of women with relapsed/refractory ovarian cancer.¹

Anixa Biosciences, the developer of the novel treatment, reported that the first-in-human trial (NCT05316129) has again successfully escalated its dose, with 2 patients now having received a dose 30 times the initial dose without experiencing dose-limiting toxicities.

Study dosing began at a single intraperitoneal or intravenous infusion of 1 x 10⁵ (100,000) FSHR T cells per kilogram of body weight; two patients have now been dosed with 3 x 10⁶ (3 million) FSHR T cells per kilogram. The 3 million cell dose is the fourth of five doses included in the study design, with the final and highest dose being 1 x10⁷ (10 million) cells per kilogram.

According to Anixa, the study has yielded early positive safety and efficacy signals.

"Our therapy continues to demonstrate a favorable safety profile, even at significantly higher cell doses," Amit Kumar, PhD, chairman and CEO of Anixa Biosciences, stated in a press release. "While this study is primarily designed to assess safety, we remain encouraged by early indications of potential efficacy as the trial progresses."

Background and CAR-T Mechanism

This autologous FSHR-targeting CAR-T product is being explored through a collaboration between Anixa and Moffitt Cancer Center. The phase 1 study is building on preclinical research showing that most ovarian cancer subtypes express FSHR, while at the same time, FSHR is not typically expressed in healthy tissue. Further, Anixa explained in the press release that their treatment uses a novel CAR-T type known as chimeric endocrine receptor-T cell technology.¹

Enrollment Criteria

The nonrandomized, open-label, parallel assignment phase 1 study is enrolling female patients aged ≥18 years with pathologically confirmed grade 1 to 3 epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma, who have progressed following at least 2 previous lines of therapy.²

Histological types should be serous, endometrioid, clear cell, mucinous, mixed epithelial, or undifferentiated. There are some additional tumor types being accepted, including borderline serous ovarian tumors, mixed invasive/borderline cancers, and certain types of sex cord-stromal tumors (SCSTs), such as adult-type granulosa cell tumors, Sertoli Leydig cell tumors, or SCSTs with mixed elements that include 1 or more of these types.

Patients need to have an Eastern Cooperative Oncology Group status of 2 or better, or a Karnofsky Performance Status score of at least 60%. Unless contraindicated, patients with germline or somatic BRCA mutations should receive PARP inhibitor treatment prior to enrollment.

The following are other requirements and inclusion notes regarding enrollment: patients must have received at least 2 previous chemotherapy regimens, including 1 that is platinum-based; up to 8 prior chemotherapy regimens are allowed; prior hormonal therapy is allowed; patients should be platinum resistant/refractory and have no other standard treatment options likely to provide a significant benefit; prior biologic/targeted therapy is allowed; a folate receptor–alpha antibody-drug conjugate, such as mirvetuximab (Elahere) should at least have been considered prior to enrollment for patients with high-grade serous disease.

The primary outcome measure of the study is the maximum tolerated dose of FSHR T cells. Secondary end points include duration of response, duration of stable disease, and overall survival.

This is a single-location study being conducted at the Moffitt Cancer Center & Research Institute in Tampa, Florida.

REFERENCES:

1. Anixa Biosciences, Inc. Anixa Biosciences announces treatment of second patient in fourth cohort of ovarian cancer CAR-T clinical trial. PR Newswire. Published August 18, 2025. Accessed August 18, 2025. https://tinyurl.com/4kh4jddd

2. Infusion of autologous T cells engineered to target FSH receptor in recurrent ovarian cancer. ClinicalTrials.gov. NCT05316129. Updated May 20, 2025. Accessed August 18, 2025. https://clinicaltrials.gov/study/NCT05316129