Seattle Children's Hospital
A phase 1, open-label, non-randomized study enrolling pediatric and young adult patients with relapsed or refractory CD33+ leukemia with and without prior history of allogeneic hematopoietic cell transplantation, to examine the safety and feasibility of administering an autologous T cell product that has been genetically modified to express a Dimerizing Agent Regulated Immunoreceptor Complex (DARIC).
Inclusion Criteria: 1. Subject age ≤ 30 years. The first three enrolled subjects must be ≥ 18 years of age. 2. AML that expresses CD33 by flow cytometry and meets one of the below definitions: 1. For subjects who have previously received an allogeneic HCT, any evidence of AML re-emergence post HCT detectable by flow cytometry 2. First relapse of AML ≤ 6 months of initial diagnosis 3. First relapse of AML \> 6 months after initial diagnosis, with MRD of \>0.1% by flow cytometry (MPF) after at least one re-induction (single cycle) attempt 4. Second or greater relapse AML 5. Refr…
Infusion with SC-DARIC33 followed by intermittent oral rapamycin administration
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