A Pediatric Trial of Genetically Modified Autologous T Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia

B Cell Leukemia Clinical Trial

Official title:
Pediatric Leukemia Adoptive Therapy (PLAT)-01: A Phase 1 Feasibility and Safety Study of Cellular Immunotherapy for Relapsed Pediatric CD19+ Acute Lymphoblastic Leukemia Using Autologous T-cells Lentivirally Transduced To Express a CD19-Specific Chimeric Antigen Receptor

Status Active, not recruiting

Clinical Trial Summary

Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use a patient's own T cells, which can be genetically modified to expresses a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the leukemic cells though the recognition of CD19, a protein expressed on the surface of the majority of pediatric ALL. This is a phase I study designed to determine the maximum tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic cells.

Clinical Trial Description

Upon meeting the eligibility requirements and enrolling on study, subjects will undergo a blood draw to obtain the T cells for the generation of the CD19 CAR+ T cells. The T cells are isolated from the blood, transduced with a lentivirus to express the CD19 CAR, and expanded in culture over a three week period. During the process of cell generation, subjects will continue to be cared for by their primary oncologist and may undergo additional treatment directed at the leukemia during this time. After the CAR+ T cells have been generated, the subject undergoes a disease assessment and will be admitted to the hospital to receive 2 days of cyclophosphamide for lymphodepletion and reduction of disease burden. Several days later, the subject will receive an infusion of the CAR+ T cells. Following treatment with the CAR+ T cells, subjects will be intensely followed for 6 weeks with serial blood testing and re-evaluation of disease status with bone marrow aspirates. After 6 weeks, the subjects clinical care will be resumed by their primary oncologist, and it is possible that they would receive additionally chemotherapy or a stem cell transplant. Upon completion of the study, subjects will be followed at least annually with a either a medical history, physical exam and blood tests or a phone call/questionnaire for 15 years. This follow up will help to determine if the subject develops any long-term health problems related to the CAR+ T cells including a new cancer. ;

Study Design

Related Conditions & MeSH terms

B Cell Leukemia
Leukemia
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Clinical Trial Details

NCT number	NCT01683279
Study type	Interventional
Source	Seattle Children's Hospital
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	March 25, 2012
Completion date	January 7, 2030

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03463928` - A Feasibility and Safety Study of Concomitant Therapy With Allo-CAR-T Cells and Allo-HSCT in Patients With Relapse or Refractory Leukemia	Phase 1
Recruiting	`NCT04516551` - Anti-CD19 Allo-CAR-T Cells for Relapsed B Cell Malignancies After HSCT	Phase 1
Recruiting	`NCT03383952` - A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia	Phase 1
Recruiting	`NCT03166878` - A Study Evaluating UCART019 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma	Phase 1/Phase 2
Recruiting	`NCT04747093` - Induced-T Cell Like NK Cells for B Cell Malignancies	Phase 1/Phase 2
Recruiting	`NCT03398967` - A Feasibility and Safety Study of Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cell Immunotherapy for Relapsed or Refractory Leukemia and Lymphoma	Phase 1/Phase 2
Recruiting	`NCT03881774` - Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies	Phase 1
Recruiting	`NCT04156243` - CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies	Early Phase 1
Active, not recruiting	`NCT03302403` - Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors	N/A
Completed	`NCT01626495` - Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma	Phase 1/Phase 2
Recruiting	`NCT04156178` - CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies	Early Phase 1
Not yet recruiting	`NCT05779930` - Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed/Refractory CD19 Positive ALL and NHL	Early Phase 1
Completed	`NCT02132624` - CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.	Phase 1/Phase 2
Completed	`NCT05095155` - Study of the Prognostic Role of Gene Polymorphism in the Development of B-cell Leukemias and Lymphomas in Children of Kazakh Nationality

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.