Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seattle Children's Hospital
Age
0–30
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
First 2 subjects: male and female subjects age ≥18 and \< 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects \<31 years.
Diagnosis of CD19+22+ leukemia
Disease status:
* If post allogeneic HCT: Confirmed CD19+CD22+ leukemia recurrence defined as at least 0.01% disease following allogeneic HCT
* If relapse/refractory status with no prior history of allogeneic HCT, one of the following:
* Second or greater marrow relapse, with or without extramedullary disease
* First marrow relapse at end of first month or re-induction with marrow having at least 0.01 % blasts by morphology and/or MPF
* Primary refractory as defined as greater than 5% blasts by multi-parameter flow after at least 2 separate induction regimens.
* Subject has indication for HCT but has been deemed ineligible, inclusive of persistent MRD prior to HCT
Asymptomatic from CNS involvement, if present, and in the opinion of the Principal Investigator with 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 prior to enrollment
Lansky or Karnofsky performance score of at least 50
Life expectancy of at least 8 weeks
Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
At least 7 days post last chemotherapy administration (excluding intrathecal maintenance chemotherapy)
At least 7 das post last systemic corticosteroids administration (unless physiologic replacement dosing)
No prior genetically modified cell therapy that is still detectable or virotherapy
Adequate organ function
Adequate laboratory values
Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion
Patients of childbearing/fathering potential must agree to use highly effective contraception from the time of initial T cell infusion through 12 months following the last T cell infusion
You may not be if
Presence of active clinically significant CNS dysfunction
Pregnant or breast-feeding
Unable to tolerate apheresis procedure
Presence of active malignancy other than CD19+CD22+ leukemia
Presence of active severe infection
Presence of any concurrent medical condition that, in the opinion of the Principal Investigator, would prevent the patient from undergoing protocol-specified therapy
Clareo Health | A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia
