Early ovarian cancer trial seeking participants to test higher therapy dose
Small study is assessing safety of cell therapy for hard-to-treat cancer
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An early-stage U.S. clinical trial testing the infusion treatment liraltagene autoleucel (lira-cel) for ovarian cancer is now seeking women whose cancer has proven hard to treat to enroll in a fifth dosing group — one that’s assessing the cell therapy at the highest dose to date.
That’s according to an update from lira-cel’s developer, Anixa Biosciences, which reported that, thus far, two patients in this cohort have received the experimental therapy. The Phase 1 clinical trial (NCT05316129), sponsored by the Moffitt Cancer Center in Florida, is still enrolling women with ovarian cancer that has failed to respond to prior treatments. Recruitment is ongoing at Moffitt in Tampa.
In the fifth dosing group, all participants will receive a one-time treatment with lira-cel at a dose of 10 million cells per kilogram of body weight.
“We look forward to further evaluating this novel solid tumor-specific CAR-T therapy as enrollment progresses,” Amit Kumar, PhD, chairman and CEO of Anixa, said in a company press release providing trial updates.
Noting that “patients with recurrent disease face limited treatment options and poor outcomes,” Kumar said researchers have been heartened by the results seen with the lira-cel thus far.
Lira-cel is an autologous CAR T-cell therapy, a treatment that harnesses the cancer-killing abilities of a patient’s own immune system. In this type of therapy, T-cells, a type of immune cell. are removed from the patient and equipped in a lab with a human-made molecular receptor called a CAR, short for chimeric antigen receptor. That CAR directs the cells to attack a specific target.
‘Multiple patients’ surviving for over 1 year after treatment
For lira-cel, the CAR targets a protein called FSHR that is commonly expressed by ovarian cancer cells.
After being equipped with the CAR, the modified T-cells are infused back into the patient to target the cancer. Prior to treatment, patients undergo lymphodepletion, in which chemotherapy is administered to eliminate existing immune cells, making room for the therapeutic cells.
The ongoing Phase 1 trial is testing two routes of administration for lira-cel: intravenous, or into the bloodstream, and intraperitoneal, delivered directly into the abdominal cavity.
The study’s main goal is to evaluate the safety of lira-cel at varying doses. Specifically, the trial aims to identify the therapy’s maximum tolerated dose, meaning the highest dose that can be given without unacceptable safety consequences. So far, no side effects suggesting this dose has been reached have been observed, according to Anixa.
While this Phase 1 study is primarily designed to evaluate safety, we are highly encouraged that multiple patients have surpassed one year of survival following treatment, with one patient having survived beyond two years.
The company also reported that some patients in the small study had longer than expected survival: Three patients lived for about 1.5 years after lira-cel treatment, and one survived nearly 2.5 years. Importantly, participants in the Phase 1 trial must have a life expectancy of at least three months to be eligible for participation.
“While this Phase 1 study is primarily designed to evaluate safety, we are highly encouraged that multiple patients have surpassed one year of survival following treatment, with one patient having survived beyond two years. Typically, these highly pre-treated patients survive a matter of weeks,” Kumar said.
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