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.
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
Interventions
Drug | Synonyms | Arms |
---|
SCRI-huCAR19v1 | | SCRI-huCAR19v1 - [CLOSED] |
SCRI-huCAR19v2 | | SCRI-huCAR19v2 |
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
Name | Type | Description | Interventions |
---|
SCRI-huCAR19v2 | Experimental | Patients will receive SCRI-huCAR19v2 in either Phase 1 or Phase II | |
SCRI-huCAR19v1 - [CLOSED] | Experimental | Patients will receive SCRI-huCAR19v1 in either Phase 1 or Phase II. As of 02/13/2020 this study cohort is permanently closed. | |
Eligibility Criteria
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
Maximum Eligible Age: | 30 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: | Active, not recruiting |
Lead Sponsor: | Seattle Children's Hospital |
Trial Keywords
- CAR T cell, CD19, pediatric, young adults
Last Updated
February 10, 2021