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
Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
Evidence of refractory or recurrent CD22+ leukemia or lymphoma
Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.
Life expectancy ≥ 8 weeks
Lansky or Karnofsky, as applicable, score ≥ 50
Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells
≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy
≥ 7 days post last corticosteroid therapy
≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use
≥ 1 day post hydroxyurea
30 days post most recent CAR T cell infusion
Adequate organ function
Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL
Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
Subject and/or legally authorized representative has signed the informed consent form for this study
You may not be if
Presence of active malignancy other than disease under study
History of symptomatic CNS pathology or ongoing symptomatic CNS pathology
CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion
Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy
For subjects having had a previous stem cell transplant: presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
Presence of active severe infection,
Presence of primary immunodeficiency syndrome
Subject has received prior virotherapy
Pregnant or breastfeeding
Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow-up period, required if CAR T cell therapy is administered
Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
