Donor-Derived Anti-CD33 CAR T Cell Therapy (VCAR33) in Patients With Relapsed or Refractory AML After Allogeneic Hematopoietic Cell Transplant

Exclusion Criteria

• •1. Patients who have undergone more than one alloHCT
• •2. Patients who have undergone alloHCT with a mismatched unrelated donor, haploidentical donor, or with umbilical cord blood as the stem cell source
• •3. Patients who will be less than 100 days post-alloHCT at the time of VCAR33 infusion.
• •4. Patients with any history of Grade III or IV acute GVHD or severe chronic GVHD unless approved by the Sponsor Medical Monitor
• •5. Patients with evidence of ongoing active acute or chronic GVHD and are taking systemic immunosuppressive agents (\> 10 mg daily of prednisone equivalent or other GVHD-directed treatment, including extracorporeal photopheresis). Patients with Grade 1 acute GVHD limited to the skin or mild chronic GVHD limited to the eyes, mouth, or skin controlled with only topical therapy are eligible.
• •6. Patients with active CNS disease. A lumbar puncture is not required to exclude CNS disease in the absence of clinical signs or symptoms suggesting CNS disease.
• •7. Patients with the following prior therapy:
• •1. DLI within 28 days prior to enrollment
• •2. Prior treatment with any CAR T cell therapy product
• •8. Patients with active or uncontrolled viral, bacterial, or fungal infection
• •9. Patients with a history of a human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection
• •10. Patients with a history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, or breast) unless disease free for at least 3 years after the last definitive therapy
• •11. Female patients of childbearing potential who are pregnant or breastfeeding