Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia

[...] rd allogenic donor stem cell transplant Performance status: >≥ 50% (for subjects > 16 years of age use Karnofsky ≥ 50%; su [...] al ULN (< grade 3) Renal function: Serum creatinine must be <≤ 1.2 x institutional upper limit of normal (ULN) according t [...] x ULN, the patient must have a creatinine clearance (CrCl) >≥ 70mL/min/1.73 m2 (measured by 24 hour- urine specimen or radioisotope GFR). Subjects >≥ 18 years of age must have the ability to give informed cons [...] citabine and/or venetoclax: 7 days Intrathecal chemotherapy >≥ 3 days Tyrosine kinase inhibitors: 3 half-lives or 7 days, [...]

[...] entified with a plan to proceed to HCT conditioning within 6-8 weeks of CD33CART cell infusion. Patients with two prior allogenic donor stem cell transplants must be medically fit for a third allogenic donor stem cell transplant Performance status: > 50% (for subjects > 16 years of age us [...] . May be receiving ongoing therapy for controlled infection Treatment with any prior CAR-T therapy product Recent prior therapy: At treatment enrollment: Patients may [...] s measurable/evaluable disease outside the radiation field. CAR T-cell therapy: Excluded unless at least 30 days from prior CAR T-cell infusion [...] [...]

[...] y flow cytometry Age: Greater than or equal to 1 year of age (and at least 15 kg) and less than or equal to 35 years of age at time of enrollment. (NOTE: The first three subjects treated on this trial must be ≥ 16 years of age) All subjects must have an allogeneic HCT donor identified wi [...] with any prior CAR-T therapy product Recent prior therapy: SystemicAt chemotherapytreatment ≤ 2 weeksenrollment: TKI ≤ 2 weeks Exceptions: 6 weeks for gemtuzumab or other CD33-targeted antibody, clofarabine or nitrosoureas; Exception: Subjects who are on azacytidine/decitabinePatients may be enrolledon provide [...] [...]

[...] otherapy is discontinued at least 1 week prior to apheresis) or There is no time restriction in regard to prior intrathecal [...] IT therapy should be performed > 72 hours prior to apheresis;: Steroid therapy is not allowed, unless at or below physiolo [...] lignancy will not be eligible with the following exceptions: a. Treatment-related or secondary CD33+ myeloid malignancy whi [...] nefit from CD33CART (which may be considered for enrollment)., b. Carcinoma in situ of the cervix (which may be considered for enrollment), c. Subject is in remission from a prior second malignancy (whi [...]

[...] year of age (and at least 15 kg) and less than or equal to 3035 years of age at time of enrollment. (NOTE: The first three [...]

[...] ygen saturation > 92% on room air at rest Hepatic function: i. Total bilirubin < grade 2 bilirubin CTCAE version 5 (<3 x UL [...] se of subjects with documented Gilbert's disease > 3 x ULN) ii. AST (SGOT)/ALT (SGPT) < 5 x institutional ULN (< grade 3) d. Renal function: Serum creatinine must be < 1.2 x institutio [...] . May be receiving ongoing therapy for controlled infection Treatment with any prior CAR-T therapy product Recent prior therapy: Systemic chemotherapy ≤ 2 weeks TKI ≤ 2 weeks Exceptions: 6 weeks for gemtuzumab or other CD33-targeted an [...] radiation will require a 3-week washout prior to enrollmen [...]