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Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through the recognition of CD22, a protein expressed on the surface of the leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to treat patients with CD22+ leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous CD22-specific CAR T-cells expressing EGFRt | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-derived CD22-specific CAR T-cells also expressing an EGFRt | Biological | Patient-derived CD22-specific chimeric antigen receptor T-cells expressing an EGFRt |
|
| Measure | Description | Time Frame |
|---|---|---|
| The adverse events associated with one or multiple CAR T-cell product infusions will be assessed | The type, frequency, severity, and duration of adverse events will be summarized | 30 days |
| The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed | Proportion of products successfully manufactured and infused | 28 days |
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Inclusion Criteria:
First 3 subjects: male and female subjects age ≥ 18 years and < 27 years
Subsequent subjects: 12 months of age and <27 years of age at the time of study enrollment
Disease status (one of the following):
If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease
If Relapse/Refractory status with no prior history of allogeneic HCT, one of:
CD22+ Lymphoma refractory or relapsed with no known curative therapies available
Asymptomatic from CNS involvement, if present, and have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T-cell infusion. Subjects with significant neurologic deterioration will not be eligible for T-cell infusion until stabilized.
Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks.
Lansky or Karnofsky performance score of ≥50
Life expectancy of >8 weeks
Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
≥7 days post last chemotherapy administration (excluding intrathecal or maintenance chemotherapy)
≥7 days post last systemic corticosteroid administration
No prior virotherapy
Adequate organ function
Adequate laboratory values
Patients of childbearing/fathering potential must agree to use highly effective contraception
Signed a written consent
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 |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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