eligibility_summary
Eligible: ≥12, consent, CD4+ AML refractory to 1L and any approved 2L. Labs/org: CrCl>60, ALT/AST<3×ULN, bili<2×ULN, DLCO≥60%, EF≥50%, apheresis access, donor IDd. Exclude: CD4− AML, pregnant/lactating, active/uncontrolled infection, active HBV/HCV unless treated/undetectable, high-dose steroids, prior gene therapy, HIV, live vaccine ≤30d, active autoimmune on systemic Tx, other active malignancy, investigational Tx ≤6mo. Infusion: stable organs, afebrile, minimal steroids, product released.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD4CAR, an autologous biological cellular gene therapy (CAR T cells). Patient T cells are lentivirally transduced to express an anti‑CD4 scFv (from humanized mAb ibalizumab) linked to a third‑generation CAR with CD28 and 4‑1BB co‑stimulatory domains and a CD3ζ activation domain, given as a single IV dose after lymphodepleting chemotherapy. Mechanism: Upon binding CD4, CAR T cells activate via CD3ζ with CD28/4‑1BB co‑stimulation, expand, and kill CD4+ leukemic blasts to reduce residual disease as a bridge to allogeneic transplant. Targets: CD4 on AML blasts (especially monocytic AML), T‑cell signaling pathways (CD28/4‑1BB/CD3ζ). Expected on‑target effect: depletion of normal CD4+ T cells (T‑cell aplasia). Design: single‑arm, Phase 1, 3+3 dose escalation.