TACL T2020-006, A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients with Relapsed or Refractory CD123 Expressing Hematologic Malignancies
TACL T2020-006
What is the goal of the study?
T2020-006 is a phase 1 study designed to evaluate the toxicity profile of tagraxofusp given alone and in combination with chemotherapy in pediatric patients with relapsed or refractory CD123-expressing hematologic malignancies. Tagraxofusp is a protein-drug conjugate consisting of a diphtheria toxin redirected to target CD123. The trial is separated into two parts. Part 1 will evaluate the safety and tolerability of tagraxofusp monotherapy, with a single dose de-escalation and single dose escalation, and establish the recommended phase 2 dose (RP2D) for tagraxofusp monotherapy. Part 2 will evaluate the safety and tolerability of tagraxofusp given in combination with chemotherapy in three separate cohorts, based on the combination chemotherapy given. Part 2 will start one dose level below the RP2D established in Part 1 for tagraxofusp monotherapy, with a single escalation possible for each cohort. Patients may receive up to 5 subsequent cycles of tagraxofusp monotherapy. The objectives of this study are to determine the RP2D of tagraxofusp given alone and in combination with chemotherapy, as well as to describe the toxicities, pharmacokinetics, and pharmacodynamic properties of tagraxofusp in pediatric patients. T2020-006 includes correlative laboratory studies to identify biomarkers to predict toxicities and response to tagraxofusp.
Who can participate in the study?
Please contact the study team listed below to learn more.