Seattle, Washington 98105


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.


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, with the exception of intrathecal chemotherapy and maintenance chemotherapy - 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 - Subjects of childbearing or child-fathering potential must agree to use highly effective contraception - Subject and/or legally authorized representative has signed the informed consent form for this study 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 and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion - 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 - Subject has received prior virotherapy - Pregnant or breastfeeding - Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow up period, required if CAR T cell therapy is administered - Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol


NCT ID:

NCT03684889


Primary Contact:

Study Chair
Colleen Annesley, MD
Seattle Children's Hospital

Colleen Annesley, MD
Phone: 206-987-2106
Email: CBDCIntake@seattlechildrens.org


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98105
United States

Colleen Annesley, MD
Phone: 206-987-2106
Email: CBDCIntake@seattlechildrens.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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