A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 1 - 26 |
| Updated: | 2/17/2019 |
| Start Date: | July 27, 2017 |
| End Date: | July 2035 |
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-04: A Phase 1 Feasibility and Safety Study of CD22-CAR T Cell Immunotherapy for CD22+ Leukemia and Lymphoma
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.
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.
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):
1. If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia
recurrence, defined as ≥0.01% disease
2. If Relapse/Refractory status with no prior history of allogeneic HCT, one of:
- 2nd or grater marrow relapse, with or without extramedullary disease
- 1st marrow relapse at end of 1st month of re-induction with marrow having
≥0.01% blasts by morphology and/or MPF
- Primary Refractory, defined as >5% blasts by multi-parameter flow after ≥2
separate induction regimens
- Subject has indication for HCT but is ineligible, inclusive of persistent
minimal residual disease
3. 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:
- Presence of active clinically significant CNS dysfunction
- Pregnant or breastfeeding
- Unable to tolerate apheresis procedure, including placement of temporary apheresis
line if required
- Presence of active malignancy other than CD22+ leukemia or lymphoma
- Presence of active severe infection
- Presence of any concurrent medical condition that would prevent the patient from
undergoing protocol-based therapy
- Presence of primary immunodeficiency/bone marrow failure syndrome
- Unwilling to participate in 15-year follow-up period that is required if CAR T cell
therapy is administered
We found this trial at
1
site
4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Corinne Summers, MD
Phone: 206-987-2106
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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