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ACTIVE NOT RECRUITING

NCT01683279

PHASE1

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

Sponsor: Seattle Children's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Year - 26 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2012-03-25

Completion Date

2030-01-07

Last Updated

2025-06-17

Healthy Volunteers

Conditions

B Cell Leukemia

Interventions

BIOLOGICAL

Autologous CD19 CAR+ EGFTt + T cells

Autologous T cell modified to express a CD19 specific CAR and a truncated EGFRt tag

Inclusion Criteria: * CD19+ Leukemia in 1st marrow relapse with MRD at the end of 1st month of re-induction * CD19+ Leukemia in 2nd or greater relapse * CD19+ Leukemia with indication for HCT, but has contraindication * Age between 1 and 26 years of age * Karnofsky of \>50 or Lansky \>50 * Life Expectancy \>12 weeks * Able to tolerate a blood draw of 4-6mL/kg * Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy * absolute lymphocyte count of \>/=750 cell/mm3 or \>/=500 is \>20kg * creatinine clearance or radioisotope GFR \>/= 70mL/min/1.73m2 OR normal serum creatinine based on age/gender * total bilirubin \</= 1.5x upper limit normal OR direct bilirubin \</= 1.5mg/dl * ALT \</= 3x upper limit normal * corrected QTc \<450msec of ECG * Shortening Fraction \>28% by ECHO or Ejection Fraction \>50% by MUGA * Documented negative HIV, Hep B and Hep C * Agree to long-term follow up for up to 15 years if they receive T cell infusion Exclusion Criteria: * Philadelphia Positive Leukemia * Prior Allogeneic Stem Cell Transplant * CNS 2 or 3 * prior cellular immunotherapy with chimeric antigen receptor modified T cells * fully humanized antibodies within three half lives * systemic corticosteroids within 7 days of enrollment * requires supplemental oxygen or has a chest X-ray with an infectious process * CNS pathology (seizure disorder, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) * Pregnant or breastfeeding women. Female participant of reproductive age must have a negative pregnancy test and agree to contraception for 1 year after T cell infusion. * Active Malignancy other than CD19+ Leukemia * Active severe infection defined as a positive blood culture within 48 hours of study enrollment or a fever \>38.2C AND clinical signs of infection within 48 hours of study enrollment * Patient has a concurrent medical condition, that in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy. * Trisomy 21 * Primary immunodeficiency/bone marrow failure syndrome

Locations (1)

Seattle Children's Hospital

Seattle, Washington, United States