eligibility_summary
Adults (≥18) with consenting CD4+ CMML refractory/relapsed, adequate function: CrCl≥60, AST/ALT<3×ULN, bili<2×ULN, DLCO≥50%, EF≥50%, and apheresis access. Exclude: CD4− CMML, pregnancy/lactation, uncontrolled infection, active HBV/HCV (unless treated/undetectable), HIV, high-dose/chronic steroids, prior gene therapy, recent live vaccine/trials, active autoimmune needing systemic tx, other active cancers. Infusion: afebrile, stable organs, off steroids ≥3 days, product released. Contraception: neg test, dual methods to 90 days.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD4CAR, an autologous chimeric antigen receptor T‑cell therapy. Patient T cells are lentivirally transduced to express an anti‑CD4 single‑chain variable fragment derived from the humanized mAb ibalizumab, fused to third‑generation signaling domains (CD28 and 4‑1BB co‑stimulation plus CD3ζ activation). Single IV infusion after lymphodepleting chemotherapy. Mechanism: CAR engagement of CD4 activates T‑cell cytotoxicity, proliferation, and cytokine release, CD28/4‑1BB enhance expansion/persistence. Targets: CD4 antigen on CD4+ CMML cells, expected on‑target depletion of normal CD4+ T‑helper/Treg cells (T‑cell aplasia). Pathways: CAR/TCR signaling via CD3ζ with CD28 and 4‑1BB co‑stimulatory pathways, downstream inflammatory cytokines (CRS risk). Primary aim: safety/feasibility and dose finding.