CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 21 years
- Gender
- Both males and females
Description
This study will evaluate the safety and maximum tolerated dose of CD123-CAR T cells. This study contains 2 phases.The first part is the called the "Collection and Manufacturing Phase" and the second is the "Treatment Phase". The Collection and Manufacturing Phase refers to your blood cells being col...
This study will evaluate the safety and maximum tolerated dose of CD123-CAR T cells. This study contains 2 phases.The first part is the called the "Collection and Manufacturing Phase" and the second is the "Treatment Phase". The Collection and Manufacturing Phase refers to your blood cells being collected and possibly frozen, via a process called apheresis. These cells will then be changed to improve their ability to recognize and kill cancer cells. The Treatment Phase refers to the portion of the study in which you receive an infusion of the CD123+ CAR cells that were made in the Collection and Manufacturing Phase; chemotherapy is often given for several days prior to the cellular infusion. You are then monitored for any possible side effects. Chemotherapy is typically given to get your body ready to accept the CATCHAML treatment. Treatment Schedule: Patients will receive lymphodepleting chemotherapy followed by infusion of CD123-CAR T cells Fludarabine on day -4, -3 and -2 Cyclophosphamide on day -2 REST DAY on day -1 CD123+CAR cell infusion on day 0 or +1
Tracking Information
- NCT #
- NCT04318678
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Paulina Velasquez, MD St. Jude Children's Hospital