CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma
- Conditions
- LeukemiaLymphoma
- Interventions
- Biological: SCRI-huCAR19v2Biological: SCRI-huCAR19v1
- Registration Number
- NCT03684889
- Lead Sponsor
- Seattle Children's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 16
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Male and female subjects age ≥ 1 and ≤ 30 years
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First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
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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
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Able to tolerate apheresis, or has sufficient existing apheresis product or T cells for manufacturing investigational product
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Life expectancy ≥ 8 weeks
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Lansky or Karnofsky, as applicable, score ≥ 50
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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
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≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy
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No prior virotherapy
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≥ 7 days post last corticosteroid therapy
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≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use
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≥ 1 day post hydroxyurea
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30 days post most recent CAR T cell infusion
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Adequate organ function
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Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL
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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
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Subject and/or legally authorized representative has signed the informed consent form for this study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SCRI-huCAR19v2 SCRI-huCAR19v2 Patients will receive SCRI-huCAR19v2 in either Phase 1 or Phase II SCRI-huCAR19v1 - [CLOSED] SCRI-huCAR19v1 Patients will receive SCRI-huCAR19v1 in either Phase 1 or Phase II. As of 02/13/2020 this study cohort is permanently closed.
- Primary Outcome Measures
Name Time Method The adverse events associated with CAR T cell product infusions will be assessed 30 days The type, frequency, severity, and duration of adverse events will be summarized
The leukemia response to SCRI-huCAR19 in subjects with relapsed or refractory CD19+ leukemia will be assessed 63 days Response will be defined by standard bone marrow assessment and standard response criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States