Anixa Biosciences announces approval of protocol amendment for CAR-T trial

Anixa Biosciences (ANIX) announced that it, along with its partner Moffitt Cancer Center, has received approval for an amendment to the protocol governing its ongoing clinical trial using CAR-T therapy for the treatment of ovarian cancer. The key changes in the protocol allows patients who may benefit from a second dose of the CAR-T therapy to receive it and expands enrollment eligibility to include patients with sex cord-stromal tumors and Sertoli Leydig cell tumors. Previously, Anixa and Moffitt had secured a single patient IND approval for an additional dose for a patient whose biopsy showed cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy. With this amendment, all eligible patients in the trial can receive a second dose of the CAR-T therapy without the need to submit individual INDs for each case.