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A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia and Lymphoma (PLAT-05)

This study is currently recruiting participants.
Verified November 2017 by Rebecca Gardner, Seattle Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03330691
First Posted: November 2, 2017
Last Update Posted: November 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rebecca Gardner, Seattle Children's Hospital
  Purpose
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 Intervention Phase
Leukemia Lymphoma Biological: Patient-derived CD19- and CD22 specific CAR Phase 1

Study Type: Interventional
Study Design: 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 and Lymphoma

Resource links provided by NLM:


Further study details as provided by Rebecca Gardner, Seattle Children's Hospital:

Primary Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 33
Actual Study Start Date: November 3, 2017
Estimated Study Completion Date: November 3, 2034
Estimated Primary Completion Date: November 3, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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.
    • Patient has indication for HCT but has been deemed ineligible, inclusive of persistent MRD
  • 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
    • 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)
    • Adequate organ function

Exclusion Criteria:

  • Requiring systemic corticosteroids (exclusive of physiologic replacement dosing) within 7 days of enrollment
  • Previously received genetically modified cell therapy that is still detectable, or virotherapy
  • Active clinically significant CNS dysfunction
  • Active malignancy other than CD19+CD22+ leukemia
  • Active severe infection
  • Concurrent medical condition that, in the opinion of the Principal Investigator, would prevent the patient from undergoing protocol-specified therapy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03330691


Contacts
Contact: Heidi Ullom, RN 206-987-2553 immunotherapy@seattlechildrens.org
Contact: Alex Brooks 206-884-1029 immunotherapy@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Rebecca Gardner, MD    206-987-2106      
Principal Investigator: Rebecca Gardner, MD         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Study Chair: Rebecca Gardner, MD Seattle Children's Hospital
  More Information

Responsible Party: Rebecca Gardner, Study Chair, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03330691     History of Changes
Other Study ID Numbers: PLAT-05
First Submitted: October 31, 2017
First Posted: November 2, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
CD19
CD22
CAR T-cell

Additional relevant MeSH terms:
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases