Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 43
Summary
- Conditions
- Acute Myelogenous Leukemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A 3+3 dose escalation design will be used to determine maximum tolerated dose in Phase 1 and Simon's two-stage design will be used to evaluate the efficacy of CD33CART in Phase 2.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 35 years
- Gender
- Both males and females
Description
This study consists of two phases. The objectives of Phase 1 and Phase 2 are: Phase 1: To determine the maximum tolerated dose of lentivirally-transduced CD33-redirected CAR-T cells (CD33CART) in children and young adults with relapsed/refractory AML Phase 2: To determine the percentage of subjects ...
This study consists of two phases. The objectives of Phase 1 and Phase 2 are: Phase 1: To determine the maximum tolerated dose of lentivirally-transduced CD33-redirected CAR-T cells (CD33CART) in children and young adults with relapsed/refractory AML Phase 2: To determine the percentage of subjects treated with CD33CART who achieve morphologic remission (<5% blasts in marrow) at Day 28 post-CD33CART cell infusion
Tracking Information
- NCT #
- NCT03971799
- Collaborators
- National Marrow Donor Program
- St. Baldrick's Foundation
- Investigators
- Principal Investigator: Nirali Shah, MD, MHSc National Cancer Institute (NCI) Principal Investigator: Richard Aplenc, MD, PhD Children's Hospital of Philadelphia
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