Clinical Trials /

CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma

NCT03684889

Description:

Patients with relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a fully human chimeric antigen receptor (CAR). The CAR used in this study can recognize CD19, a protein expressed on the surface of leukemia and lymphoma cells. The fully human CAR used in this study may help protect against rejection of the CAR T cells, which in turn could lead to lasting protection against return of the leukemia or lymphoma. The phase 1 part of this study will determine the safety of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.

Related Conditions:
  • Leukemia
  • Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma
  • Official Title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-06: A Phase 1/2 Study of CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: PLAT-06
  • NCT ID: NCT03684889

Conditions

  • Leukemia
  • Lymphoma

Interventions

DrugSynonymsArms
SCRI-huCAR19v1SCRI-huCAR19v1

Purpose

Patients with relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a fully human chimeric antigen receptor (CAR). The CAR used in this study can recognize CD19, a protein expressed on the surface of leukemia and lymphoma cells. The fully human CAR used in this study may help protect against rejection of the CAR T cells, which in turn could lead to lasting protection against return of the leukemia or lymphoma. The phase 1 part of this study will determine the safety of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.

Trial Arms

NameTypeDescriptionInterventions
SCRI-huCAR19v1ExperimentalPatients will receive SCRI-huCAR19v1 in either Phase I or Phase II
  • SCRI-huCAR19v1

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female subjects age ≥ 1 and ≤ 26 years

          -  First 2 enrolled subjects: age ≥ 18 and ≤ 26 years

          -  Evidence of refractory or recurrent CD19+ leukemia or lymphoma

          -  Able to tolerate apheresis

          -  Life expectancy ≥ 8 weeks

          -  Lansky or Karnofsky score ≥ 50

          -  Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and
             radiotherapy, if the subject does not have a previously obtained apheresis product
             that is acceptable and available for manufacturing of CAR T cells

          -  ≥ 7 days post last chemotherapy and biologic therapy

          -  No prior virotherapy

          -  ≥ 7 days post last corticosteroid therapy

          -  ≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use

          -  ≥ 1 day post hydroxyurea

          -  30 days post most recent CAR T cell infusion

          -  Adequate organ function

          -  Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL

          -  Patients of childbearing or child-fathering potential must agree to use highly
             effective contraception

        Exclusion Criteria:

          -  Presence of active malignancy other than disease under study

          -  History of symptomatic CNS pathology or ongoing symptomatic CNS pathology

          -  CNS involvement of leukemia or lymphoma that is symptomatic

          -  Presence of active GVHD, or receiving immunosuppressive therapy for treatment or
             prevention of GVHD within 4 weeks prior to enrollment

          -  Presence of active severe infection

          -  Presence of primary immunodeficiency syndrome

          -  Pregnant or breastfeeding

          -  Unwilling or unable to provide consent/assent for participation in the study and 15
             year follow up period

          -  Presence of any condition that, in the opinion of the investigator, would prohibit the
             patient from undergoing treatment under this protocol
      
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 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/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Children's Hospital

Trial Keywords

  • CAR T cell, CD19, pediatric, young adults

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