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NCT02028455Active, not recruitingPhase 1/2

A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia

Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-02: A Phase 1/2 Feasibility and Safety Study of CD19-CAR T Cell Immunotherapy for CD19+ Leukemia

Source: ClinicalTrials.gov · Last updated 6 Aug 2026

Brief summary (registry, in English)

Patients with relapsed or refractory leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia. This is a phase 1/2 study designed to determine the maximum tolerated dose of the CAR+ T cells as well as to determine the efficacy. The phase 1 cohort is restricted to those patients who have already had an allogeneic hematopoietic cell transplant (HCT). The phase 2 is open to all patients regardless of having a history of HCT.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
167 (actual)
First submitted
3 Jan 2014
Start date
11 Feb 2014
Primary completion date
10 Aug 2021
Lead sponsor
Seattle Children's Hospital
NCT number
NCT02028455

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 167
  • From 11 Feb 2014 to the primary completion date, 10 Aug 2021
  • 3 sites 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.

Who the study is looking for

  • Patients must be ≥12 months of age and \<27 years of age at the time of study enrollment.
  • Must be ≥10kg
  • Confirmed CD19+ leukemia recurrence defined as ≥0.01% disease in the marrow or isolated extramedullary disease following allogeneic HCT. \[N.B. Study closed to enrollment of leukemia subjects\]
  • OR
  • No prior history of allogeneic HCT (one of the following)
  • 2nd or greater relapse, with or without extramedullary disease (isolated extramedullary disease is eligible)
  • 1st marrow relapse at end of 1st month of re-induction with marrow having ≥0.01% blast disease, with or without extramedullary disease
  • Primary Refractory as defined as having M2 or M3 marrow after induction
  • Subject has indication for HCT but has been deemed ineligible
    • OR
    • CD19+ Non-Hodgkin Lymphoma (NHL) refractory or relapsed with no known curative therapies available \[N.B. Study remains open to enrollment of lymphoma subjects\]
    • Patients with CNS involvement are eligible provided that they are asymptomatic and in the opinion of the study PI have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T cell infusion. Patients that have a significant neurologic deterioration will be not be eligible for T cell infusion until alternate therapies result in neurological stabilization.
    • Patients must have a Lansky performance status score of ≥50 or a Karnofsky score of ≥ 50 for patients ≥16 years of age.
    • Life Expectancy of \>8 weeks
    • Patients must be free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment.
    • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
    • It must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy or maintenance chemotherapy)
    • No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment.
    • No prior genetically modified cell therapy that is still detectable or virotherapy allowed.
  • Normal serum creatinine based on age/gender
  • Total bilirubin \</3x ULN OR conjugated bilirubin \</2mg/dl
  • ALT \</5X ULN
  • SF of \>28% by ECHO or EF \>50% by MUGA
  • ALC of \>/= 100 cells/ul
  • Pulse ox \>/= 90% on room air
    • Patient must have documented negative HIV antigen and antibody, Hepatitis B surface antigen, and Hepatitis C antibody within 3 months prior to enrollment. For patient with positive Hepatitis C Ab, negative PCR testing must be documented in order to be eligible.
    • Patients must NOT have active clinically significant CNS dysfunction (including but not limited to such as uncontrolled seizure disorder, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
    • Must agree to highly effective contraception during and for 12 months after T cell infusion.
    • Patients must be able to tolerate apheresis procedure, including placement of temporary apheresis line if required.
    • Patients must NOT have an active malignancy other than CD19+ leukemia.
    • Patients must NOT have an active severe infection defined as:
  • A positive blood culture within 48 hours of study enrollment
  • A fever above 38.2 C AND clinical signs of infection within 48 hours of study enrollment
    • Patients must NOT have any concurrent medical condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy. Patients with a primary immunodeficiency/ bone marrow failure syndrome are excluded from this trial.
    • Research participant or parent/legal guardian must agree to participate in long-term follow-up for up to 15 years, if they are enrolled in the study and 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 (3)

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

SiteCityCountrySite status
Children's Hospital Los Angeles
Coordinator of this site? Confirm its status		Los AngelesUnited StatesUnknown status
Children's Hospital Oakland
Coordinator of this site? Confirm its status		OaklandUnited StatesUnknown 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.