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Trial record 1 of 1 for:    NCT03330691
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A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03330691
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : January 14, 2020
Information provided by (Responsible Party):
Rebecca Gardner, Seattle Children's Hospital

Brief Summary:
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: Patient-derived CD19- and CD22 specific CAR Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : November 3, 2020
Estimated Study Completion Date : November 3, 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: Patient-derived CD19- and CD22 specific CAR
Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt
Biological: Patient-derived CD19- and CD22 specific CAR
Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt

Primary Outcome Measures :
  1. The adverse events associated with one or multiple CAR T-cell product infusions will be assessed [ Time Frame: 30 days ]
    Type, frequency, severity, and duration of adverse events will be summarized

  2. The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed [ Time Frame: 28 days ]
    Proportion of products successfully manufactured and infused

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects: male and female subjects age ≥12 months of age and <27 years.
  • Diagnosis of CD19+22+ leukemia
  • Disease status:

    • If post allogeneic HCT: Confirmed CD19+CD22+ leukemia recurrence defined as at least 0.01% disease following allogeneic HCT
    • If relapse/refractory status with no prior history of allogeneic HCT, one of the following:
    • Second or greater marrow relapse, with or without extramedullary disease
    • First marrow relapse at end of first month or re-induction with marrow having at least 0.01 % blasts by morphology and/or MPF
    • Primary refractory as defined as greater than 5% blasts by multi-parameter flow after at least 2 separate induction regimens.
    • Subject has indication for HCT but has been deemed ineligible, inclusive of persistent MRD prior to HCT
  • Asymptomatic from CNS involvement, if present, and in the opinion of the Principal Investigator with a reasonable expectation that disease burden can be controlled in the interval between enrollment and T-cell infusion. Subjects with significant neurologic deterioration will not be eligible for T-cell infusion until stabilized.
  • Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
  • Lansky or Karnofsky performance score of at least 50
  • Life expectancy of at least 8 weeks
  • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
  • At least 7 days post last chemotherapy administration (excluding intrathecal maintenance chemotherapy)
  • At least 7 das post last systemic corticosteroids administration (unless physiologic replacement dosing)
  • No prior genetically modified cell therapy that is still detectable or virotherapy
  • Adequate organ function
  • Adequate laboratory values
  • Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion
  • Patients of childbearing/fathering potential must agree to use highly effective contraception from the time of initial T cell infusion through 12 months following the last T cell infusion

Exclusion Criteria:

  • Presence of active clinically significant CNS dysfunction
  • Pregnant or breast-feeding
  • Unable to tolerate apheresis procedure
  • Presence of active malignancy other than CD19+CD22+ leukemia
  • Presence of active severe infection
  • Presence of any concurrent medical condition that, in the opinion of the Principal Investigator, would prevent the patient from undergoing protocol-specified therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03330691

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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Canada, British Columbia
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
Seattle Children's Hospital
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Study Chair: Rebecca Gardner, MD Seattle Children's Hospital
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Responsible Party: Rebecca Gardner, Associate Medical Director, Immunotherapy Coordinating Center, Seattle Children's Hospital Identifier: NCT03330691    
Other Study ID Numbers: PLAT-05
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Gardner, Seattle Children's Hospital:
CAR T-cell
Additional relevant MeSH terms:
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Neoplasms by Histologic Type