ImmunoTech Biopharm Commences Patient Enrollment in Phase II Study for CAR-T-19 Injection

ImmunoTech Biopharm Ltd, a China-based specialist in chimeric antigen receptor T-cell (CAR-T) therapies (HKG: 6978), has announced the enrollment of the first patient in a Phase II clinical study for its CAR-T-19 injection. The treatment is under development for children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). The company anticipates concluding enrollment for the trial before the end of 2025, with preliminary analysis and results expected to be published in the first half of 2026.

Acute lymphocytic leukemia (ALL), a subtype of acute leukemia, is characterized by a rapid increase in the number of immature blood cells, where the DNA of blood cells mutates and fails to mature into normal cells. ALL is more prevalent in children than adults. In 2015, there were approximately 12,000 new B-ALL cases in China, with 30% being refractory and relapsed. The number of newly diagnosed ALL patients increased from approximately 11,600 in 2014 to approximately 13,100 in 2022. In 2022, approximately 11,500 of the new ALL cases were children under the age of 18, accounting for 87.7% of China’s total ALL population. With advancements in early screening, it is estimated that the number of new cases will rise to 13,400 by 2023 and further to 14,700 by 2030.- Flcube.com

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