Clinical Trials /

A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma

NCT03244306

Description:

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 a chimeric antigen receptor (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through the recognition of CD22, a protein expressed on the surface of the leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to treat patients with CD22+ leukemia.

Related Conditions:
  • Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study of CD22 CAR T-Cell Immunotherapy for CD22+ Leukemia
  • Official Title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-04: A Phase 1 Feasibility and Safety Study of CD22 CAR T-Cell Immunotherapy for CD22+ Leukemia

Clinical Trial IDs

  • ORG STUDY ID: PLAT-04
  • NCT ID: NCT03244306

Conditions

  • Leukemia

Interventions

DrugSynonymsArms
Patient-derived CD22-specific CAR T-cells also expressing an EGFRtAutologous CD22-specific CAR T-cells expressing EGFRt

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 a chimeric antigen receptor (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through the recognition of CD22, a protein expressed on the surface of the leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to treat patients with CD22+ leukemia.

Trial Arms

NameTypeDescriptionInterventions
Autologous CD22-specific CAR T-cells expressing EGFRtExperimental

    Eligibility Criteria

            Inclusion Criteria:
    
            ≥1 ≤26 years of age
    
            Disease status:
    
              -  If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia
                 recurrence, defined as ≥0.01% disease
    
              -  If Relapse/Refractory status with no history of allogeneic HCT, one of:
    
                   -  2nd or grater marrow relapse, with or without extramedullary disease
    
                   -  1st marrow relapse at end of 1st month of re-induction with ≥0.01% blasts by
                      morphology and/or MPF
    
                   -  Primary Refractory, defined as >5% blasts by multi-parameter flow after ≥2
                      separate induction regimens
    
                   -  Subject has indication for HCT but is ineligible, inclusive of persistent minimal
                      residual disease
    
              -  Asymptomatic from CNS involvement, if present, and in the opinion of the PI 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 ≥50
    
              -  Life expectancy of >8 weeks
    
              -  Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and
                 radiotherapy
    
              -  ≥7 days post last chemotherapy administration (excluding intrathecal or 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 CD22+ leukemia
    
              -  Active severe infection
    
              -  Concurrent medical condition that, in the opinion of the Investigator, would prevent
                 the patient from undergoing protocol specified therapy
          
    Maximum Eligible Age:26 Years
    Minimum Eligible Age:1 Year
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
    Time Frame:30 days
    Safety Issue:
    Description:The type, frequency, severity, and duration of adverse events will be summarized

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Seattle Children's Hospital

    Trial Keywords

    • leukemia
    • CD 22
    • CAR T cell
    • pediatric
    • young adult
    • chimeric antigen receptor

    Last Updated

    August 10, 2017