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

Seattle Children's Healthcare System

Status and phase

Active, not recruiting

Phase 1

Conditions

Lymphoma

Leukemia

Treatments

Biological: SCRI-huCAR19v2

Biological: SCRI-huCAR19v1

Study type

Interventional

Funder types

Other

Identifiers

NCT03684889

PLAT-06

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

1 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects age ≥ 1 and ≤ 30 years
First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
Disease requirements:
- Phase 1: Evidence of refractory or recurrent CD19+ leukemia or lymphoma following previous CAR T cell immunotherapy
- Phase 2: Evidence of refractory or recurrent CD19+ leukemia or lymphoma
Able to tolerate apheresis, or has sufficient existing apheresis product or T cells for manufacturing investigational product
Life expectancy ≥ 8 weeks
Lansky or Karnofsky, as applicable, 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 from consent through 12 months following infusion of investigational product on trial
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