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NCT01683279Active, not recruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 5 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
6 (actual)
First submitted
7 Sept 2012
Start date
25 Mar 2012
Primary completion date
7 Jan 2015
Lead sponsor
Seattle Children's Hospital
NCT number
NCT01683279

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 6
  • From 25 Mar 2012 to the primary completion date, 7 Jan 2015
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior Allogeneic Stem Cell Transplant
  • prior cellular immunotherapy with chimeric antigen receptor modified T cells
  • fully humanized antibodies within three half lives
  • systemic corticosteroids within 7 days of 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.

Other illness

  • CNS pathology (seizure disorder, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
  • 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
  • Primary immunodeficiency/bone marrow failure syndrome

Age

  • 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.

Other

  • Philadelphia Positive Leukemia
  • CNS 2 or 3
  • requires supplemental oxygen or has a chest X-ray with an infectious process
  • Trisomy 21

Who the study is looking for

  • 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

Age in the registry: 1 year to 26 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seattle Children's Hospital
Coordinator of this site? Confirm its status		SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.