Lira-cel well tolerated so far in early recurrent ovarian cancer trial
Anixa reports updated survival observations from Phase 1 study
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Liraltagene autoleucel (lira-cel), an experimental cell therapy in clinical development for recurrent ovarian cancer, has been tolerated well so far in an early clinical trial, according to an update from developer Anixa Biosciences.
The ongoing Phase 1 clinical trial (NCT05316129), sponsored by the Moffitt Cancer Center in Florida, is testing various doses of lira-cel in adult women with recurrent ovarian cancer that has progressed after at least two prior therapies. The study is still recruiting participants at the Florida center.
No dose-limiting toxicities reported so far
According to Anixa, no dose-limiting toxicities have been reported so far — meaning no side effects have been severe enough to limit further dose testing at the doses evaluated. There also have been no observations of immune effector cell-associated neurotoxicity syndrome (ICANS) or significant cytokine release syndrome (CRS), both of which are potentially serious immune-related complications that are known risks of some cell therapies. The company said all significant adverse events observed in the study so far have been unrelated to lira-cel treatment.
“While this remains an early-stage study, lira-cel has continued to demonstrate a favorable preliminary safety profile, with no dose-limiting toxicities, ICANS or CRS observed in the first three dose cohorts. We believe these findings support continued dose escalation and clinical evaluation,” Amit Kumar, PhD, chairman and CEO of Anixa, said in a company press release.
These results were presented at the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting, held May 6-9 in Dublin, Ireland, in a presentation titled “A Phase I clinical trial of an infusion of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor in patients with recurrent ovarian cancer.”
Given the preliminary safety findings, the trial is now preparing to test a higher dose of lira-cel in a new group of patients. Before receiving the cell therapy, patients in this group will receive chemotherapy medications, cyclophosphamide and fludarabine, to reduce existing immune cells and make room for the therapeutic lira-cel cells. This type of pretreatment is known as lymphodepletion.
“We look forward to treating patients in the next dose cohort, which is expected to evaluate a dose approximately three times higher than the previous cohort and to include lymphodepletion with cyclophosphamide and fludarabine. This approach may create a more favorable environment for CAR-T cell expansion, persistence and activity,” Kumar said.
Lira-cel is designed to target FSHR
Ovarian cancer is the deadliest type of gynecological cancer, marked by the abnormal growth of cells in or near the ovaries. Lira-cel is an autologous CAR T-cell therapy, meaning it uses a patient’s own immune cells. This type of treatment involves collecting cancer-killing immune cells called T-cells from a patient, then modifying them to carry a human-made receptor called a chimeric antigen receptor (CAR).
The CAR used in lira-cel directs the T-cells to target follicle-stimulating hormone receptor (FSHR), a protein found on ovarian cells, tumor blood vessels, and certain cancer cells, but not most healthy tissues.
The engineered cells are then administered back to the patient to target the cancer. Whereas most CAR T-cell therapies are given intravenously, or by infusion into the bloodstream, all participants given lira-cel in the ongoing Phase 1 study have instead received intraperitoneal administration, in which the cells are delivered into the abdominal cavity.
In addition to reporting preliminary safety findings, Anixa also provided an update on survival observations for patients enrolled in the study so far. Based on patients’ disease status at the start of the trial, most would not be expected to live longer than three or four months. But as previously reported, one participant survived more than two years after treatment.
Three patients survived more than one year after treatment, at 18, 17, and 17 months, respectively, and four others survived 11, 11, eight, and seven months, respectively. According to Anixa, three patients who reached 18, 17, and 11 months remain alive, as does one additional patient treated more recently.
“The updated survival observations from this ongoing Phase 1 trial continue to be encouraging, particularly given the advanced disease status and limited treatment options for patients with recurrent ovarian cancer,” Kumar said.
