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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCRI-CAR22v2 | Experimental | Patients will receive SCRI-CAR22v2 in either Phase I or Phase II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCRI-CAR22v2 | Biological | Single infusion of SCRI-CAR22v2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days post-infusion |
| The ability to successfully manufacture SCRI-CAR22v2 | We will measure the number of successfully manufactured SCRI-CAR22v2 products | 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 | 28 days post-infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Summers, MD | Seattle Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Riley Hospital for Children |
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| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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