NEW YORK – Pentixapharm said Thursday it has begun treating patients in a Phase I/II trial of its radiopharmaceutical therapy Lu177-PentixaTher in adult patients with relapsed or refractory CXCR4-positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).
The trial will include up to 21 patients to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher and examine efficacy endpoints such as overall response rate and complete remission after infusion of the agent. Patients will need CXCR4-positive expression in greater than or equal to 20 percent of the blast cell population to enroll.
"Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes," Pentixapharm CEO Dirk Pleimes said in a statement. "We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies."
The study is funded by the French Ministry of Health and will be led by researchers from the University Hospital in Nantes, France.
Berlin-based Pentixapharm has two other radiopharmaceuticals in development for cancer, including [68Ga]Ga-PentixaFor for marginal zone lymphoma and [90Y]Y-PentixaTher for the treatment of central nervous system lymphoma.