eligibility_summary
Adults (≥18) with CD33+ R/R AML after 8/8 HLA-matched related/unrelated alloHCT, disease: ≥5% marrow blasts (Arm A) or <5% with MRD ≥0.1% CD33+ (Arm B), ECOG 0–1, adequate cardiac/pulmonary/hepatic/renal function, original donor available for apheresis (VOR33 recipients allowed). Exclude: >1 alloHCT, mismatched/haplo/cord donors, <100 days post-HCT, significant/active GVHD or on systemic immunosuppression, CNS disease, DLI <28 d, prior CAR T, active infections, HIV/HBV/HCV, other malignancy unless disease-free ≥3y, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: VCAR33, a donor-derived anti-CD33 chimeric antigen receptor (CAR) T-cell therapy (biologic, lentiviral-transduced allogeneic T cells from the patient’s original HLA-matched alloHCT donor). Mechanism: CD33-specific CAR (scFv with T-cell activation/costimulatory domains) binds CD33 on AML cells, triggering T-cell activation, cytokine release, and cytolytic killing, depleting CD33+ leukemia and other CD33+ myeloid cells. Targets: CD33 antigen on >80% of AML blasts and normal myeloid progenitors, engages CAR T-cell signaling (CD3ζ/costimulation) to mediate tumor cell death. Study: Phase 1/2, 3+3 dose escalation in R/R AML post-alloHCT (MRD+ and morphologic cohorts), status terminated for lack of funding.