eligibility_summary
Eligible: ≤60 with confirmed hematologic malignancy—acute leukemias (AML/precursor, ALL/lymphoma) or high‑risk MDS (IPSS INT‑2/High or severe pancytopenia, transfusion dependence, or high‑risk cytogenetics/molecular), Karnofsky ≥70% (Lansky ≥50% if ≤16), adequate organ function. Exclude: pregnant/breastfeeding, uncontrolled infection ≤1 wk, HIV+ or HBV/HCV viremia, prior auto/allo transplant, CML blast crisis, active CNS malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase II, open-label study of ex vivo TCR α/β–depleted peripheral blood stem cell (PBSC) transplantation for hematologic malignancies. Interventions: α/β T-cell–depleted PBSC graft (cellular immunotherapy) to reduce GVHD while preserving γ/δ T cells and NK cells for graft‑versus‑leukemia/anti-infection. Conditioning: fludarabine (purine analog antimetabolite, lymphodepletion via DNA synthesis inhibition), busulfan, melphalan, cyclophosphamide (alkylating agents, DNA crosslinking/myeloablation), and/or total body irradiation (DNA-damaging myeloablation). Immune modulation: rabbit anti-thymocyte globulin/Thymoglobulin (polyclonal anti–T‑cell antibody, in vivo T‑cell depletion) and rituximab (anti‑CD20 monoclonal antibody, B‑cell depletion/EBV‑PTLD prophylaxis). Levetiracetam for seizure prophylaxis. Targets: donor α/β T cells, recipient/donor T and B cells, and hematopoietic precursors via DNA damage pathways.