Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03330691
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : July 22, 2019
Sponsor:
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
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, 2019
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT03330691


Contacts
Layout table for location contacts
Contact: Rebecca Gardner, MD 206-987-2106 CBDCIntake@seattlechildrens.org

Locations
Layout table for location information
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Lauren Jerkins, MD       lmclaugh@childrensnational.org   
Contact: Shanae Henry    202-476-7566    snhenry@childrensnational.org   
Principal Investigator: Lauren Jerkins, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Rebecca Gardner, MD    206-987-2106    CBDCIntake@seattlechildrens.org   
Principal Investigator: Rebecca Gardner, MD         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Layout table for investigator information
Study Chair: Rebecca Gardner, MD Seattle Children's Hospital

Layout table for additonal information
Responsible Party: Rebecca Gardner, Associate Medical Director, Immunotherapy Coordinating Center, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03330691     History of Changes
Other Study ID Numbers: PLAT-05
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Leukemia
Neoplasms by Histologic Type
Neoplasms