Clinical Trials Logo
  1. Home
  2. Acute Myelogenous Leukemia
  3. NCT03971799

Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia

Acute Myelogenous Leukemia Clinical Trial

Official title:
Phase 1/2 Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial Summary

This phase 1/2 trial aims to determine the safety and feasibility of antiCD33 chimeric antigen receptor (CAR) expressing T cells (CD33CART) in children and adolescents/young adults (AYAs) with relapsed/refractory acute myeloid leukemia (AML). The trial will be done in two phases: Phase 1 will determine the maximum tolerated dose of CD33CART cells using a 3+3 trial design, with dose-escalation for autologous products separated from dose-escalation for an allogeneic arm. Phase 2 is an expansion phase designed to evaluate the rate of response to CD33CART.

Clinical Trial Description

This study consists of two phases. The objectives of Phase 1 and Phase 2 are: Phase 1: Autologous Arm: To determine the maximum tolerated dose of lentivirally transduced autologous CD33-redirected CAR-T cells (CD33CART) in children and young adults with relapsed/refractory AML Allogeneic Arm: To determine the maximum tolerated dose of lentivirally transduced allogeneic CD33-redirected CAR-T cells (ALLO-CD33CART) in children and young adults with post-HSCT relapsed/refractory AML Phase 2: To determine the percentage of recipients treated with CD33CART who achieve morphologic remission (<5% blasts in marrow) at Day 28 post-CD33CART cell infusion ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03971799
Study type Interventional
Source Center for International Blood and Marrow Transplant Research
Contact Kristi Wilmes
Phone (763) 406-3416
Email kwilmes@nmdp.org
Status Recruiting
Phase Phase 1/Phase 2
Start date January 8, 2020
Completion date December 2039
View Details
See also
  Status Clinical Trial Phase
Completed NCT01200355 - Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome Phase 4
Active, not recruiting NCT03755414 - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation Phase 1
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Completed NCT02543879 - Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies Phase 1
Completed NCT01681537 - Lenalidomide Plus Chemotherapy for AML Phase 1
Completed NCT01385423 - Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML) Phase 1
Terminated NCT01193400 - Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years Phase 2
Completed NCT00975975 - Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer Phase 2
Completed NCT00981240 - Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes Phase 1
Completed NCT00995332 - Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine Phase 1/Phase 2
Completed NCT00726934 - The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients N/A
Completed NCT00378534 - Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants Phase 2
Completed NCT01031498 - Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting Phase 2
Completed NCT00789256 - Low Dose Melphalan and Bortezomib for AML and High-Risk MDS N/A
Completed NCT00098033 - Investigation of Clofarabine in Acute Leukemias Phase 2
Completed NCT01020539 - Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia Phase 1
Not yet recruiting NCT04709458 - Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis Phase 1
Recruiting NCT04024241 - Medium Dose of Cytarabine and Mitoxantrone
Terminated NCT02203773 - Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML) Phase 1