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 chimeric antigen receptor (CAR). The CAR used in this study can recognize CD22, a protein expressed on the surface of leukemia and lymphoma cells. The phase 1 part of this study will determine the safety and appropriate dose level 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Single infusion of SCRI-CAR22v2
Children's Hospital Los Angeles
Los Angeles, California, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
The adverse events associated with CAR T cell product infusions will be assessed
The type, frequency, severity, and duration of adverse events will be summarized
Time frame: 28 days post-infusion
The ability to successfully manufacture SCRI-CAR22v2
We will measure the number of successfully manufactured SCRI-CAR22v2 products
Time frame: 28 days
The leukemia response to SCRI-CAR22v2 in subjects with relapsed or refractory CD22+ leukemia will be assessed
The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the T cell infusion
Time frame: 28 days post-infusion
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