China Approves First CAR-T Therapy for Solid Tumors; WVU Achieves Immunotherapy Breakthrough
China has approved the world's first CAR-T cell therapy for solid tumors, specifically for stomach cancer, developed by CARsgen Therapeutics. Meanwhile, the WVU Cancer Institute has conducted the first-ever use of a subcutaneous formulation of blinatumomab to achieve remission in a patient with ultra-rare mixed phenotype acute leukemia.
China's drug regulator has approved the first CAR-T cell therapy for solid tumors, a treatment for stomach cancer, while a team at the WVU Cancer Institute has achieved a world-first in treating an ultra-rare leukemia with a novel subcutaneous immunotherapy. These separate advancements mark significant milestones in cancer treatment.
The approved injection, also known as satri-cel, is developed by CARsgen Therapeutics and is globally the first approved CAR-T cell therapy for solid tumors. CAR-T therapy works by engineering a patient's immune cells to recognize and kill cancer cells. While CAR-T therapy is already used to treat blood cancers including leukemia, lymphoma, and multiple myeloma, it has not previously been approved for solid tumors. The company stated the first patient would be dosed in at least three to four weeks following the approval.
Separately, a WVU Cancer Institute-led clinical trial has achieved a global medical first by using a subcutaneous formulation of blinatumomab to treat CD19-positive mixed phenotype acute leukemia (MPAL), one of the rarest and most aggressive forms of leukemia. MPAL accounts for only one-to-three percent of acute leukemias diagnosed, and adults with the disease face a median survival rate often measured in months, with no FDA-approved, disease-specific therapies currently available.
The investigator-initiated Phase II trial's first patient received the milestone dose on Jan. 16. After a single cycle of the subcutaneous therapy, the patient achieved complete remission with full hematologic recovery. Blinatumomab (Blincyto®) is a bispecific T-cell engager that has traditionally required continuous intravenous infusion. The trial is evaluating a subcutaneous formulation designed to deliver comparable therapeutic exposure without the burden of continuous IV administration. The trial will enroll up to 75 patients across three clinical cohorts and is expected to open at approximately 15 sites across North America.
Immunotherapies like these are part of the care provided at cancer centers. The WVU Cancer Institute also operates a patient support program called the Soup for the Soul Fund, which has provided more than 10,000 free meals to patients receiving infusions or chemotherapy since its establishment in 2015. The program aims to ease the burden on patients and families during lengthy treatment sessions.