Topics

CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)

2020-03-27 03:25:33 | BioPortfolio

Summary

The CD123+ CAR therapy is a new treatment that is being investigated for treatment of AML. The purpose of this study is to find the maximum (highest) dose of CD123+ CAR cells that is safe to give patients with AML. This would include studying the side effects of the chemotherapy, as well as the CD123+ CAR product on the recipient's body, disease and overall survival.

Primary Objective

To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ AML after lymphodepleting chemotherapy

Secondary Objectives

To evaluate the antileukemia activity of CD123-CAR T cells.

Exploratory Objectives

- To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells

- To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells

- To characterize AML blasts post CD123-CAR T-cell therapy

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 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

Study Design

Conditions

Acute Myeloid Leukemia

Intervention

CD123-CAR T, Cyclophosphamide, Fludarabine, Mesna, Rituximab

Location

St. Jude Children's Hospital
Memphis
Tennessee
United States
38105

Status

Not yet recruiting

Source

St. Jude Children's Research Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-27T03:25:33-0400

Clinical Trials [4613 Associated Clinical Trials listed on BioPortfolio]

Lentivirally Redirected CD123 Autologous T Cells in AML

Phase 1 open-label study to estimate the safety, manufacturing feasibility, and efficacy of intravenously administered, lentivirally transduced T cells expressing anti-CD123 chimeric antig...

Safety and Efficacy of Anti-CD123 CAR-T Therapy in Patients With Refractory/ Relapsed CD123+ Acute Myeloid Leukemia.

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD123 CAR-T cells in patients with refractory/relapsed CD123+ Acute Myeloid Leukemia.

CD123 CAR-T Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia

There are limited options for treatment of relapse/refractory acute myeloid leukemia (AML). CD123 CAR-T cells may have an attractive and permanent effect on anti-tumor. This study purpose ...

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them ...

Fludarabine, Cyclophosphamide, and Rituximab or Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as ritux...

PubMed Articles [7261 Associated PubMed Articles listed on BioPortfolio]

Allogeneic hemopoietic stem cell transplants in patients with acute myeloid leukemia (AML) prepared with Busulfan Fludarabine (BUFLU) or Thiotepa Busulfan Fludarabine (TBF): a retrospective study.

This is a multicenter retrospective comparison of two myeloablative conditioning regimens in 454 patients with acute myeloid leukemia (AML) in remission: busulfan (4 days) and fludarabine (BUFLU) vers...

Comparative effectiveness of busulfan/cyclophosphamide versus busulfan/fludarabine myeloablative conditioning for allogeneic hematopoietic cell transplantation in acute myeloid leukemia and myelodysplastic syndrome.

Busulfan/cyclophosphamide (Bu/Cy) and busulfan/fludarabine (Bu/Flu) are both standard myeloablative conditioning (MAC) regimens for allogeneic hematopoietic cell transplantation (alloHCT). We compared...

Outcomes of the cyclophosphamide, vincristine, prednisone (CVP) +/- rituximab (R-CVP) regimen in older patients with newly diagnosed Ph- acute lymphoblastic leukemia.

Haploidentical Transplantation for Acute Myeloid Leukemia Patients with Minimal/ Measurable Residual Disease at Transplantation.

There have been conflicting results regarding impact of minimal/measurable disease at transplant on acute myeloid leukemia (AML) outcomes after haploidentical transplantation (haplo-SCT). We assessed ...

Successful Umbilical Cord Blood Transplantation With Reduced-intensity Conditioning for Acute Myeloid Leukemia in a Child With Shwachman-Diamond Syndrome.

Outcomes of patients with Shwachman-Diamond syndrome (SDS) who developed myeloid malignancies are poor because of refractory disease and high hematopoietic stem cell transplantation-related mortality....

Medical and Biotech [MESH] Definitions

A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.

More From BioPortfolio on "CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)"

Quick Search

Relevant Topics

Cytokine Tumour Necrosis Factor (TNF)
TNF is a compound that is classified as a cytokine which plays a central role in the cellular mechanisms of apoptosis or cell death. However, there are a number of different kinds of TNF, just under twenty, but the family of molecules have very similar a...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...


Searches Linking to this Trial