eligibility_summary
Adults (≥18) with KPS ≥70 after alloHCT from original matched or haplo donor, steroid‑dependent/refractory moderate–severe cGVHD, >90‑day survival, consent/archival tissue, stable low‑dose steroids, prior FDA‑approved TKI, anti‑CD6‑naïve, adequate counts and organ/cardiopulmonary function, negative/controlled HIV/HBV/HCV/TB/COVID, contraception. Donor: original, ≥18, KPS ≥70, cleared. Exclude: recent IS meds/vaccines/DLI/investigational tx, active infection/malignancy (except skin), autoimmune/inflammatory dz, vascular/unstable cardiac dz, pregnancy/breastfeeding, allergy/contraindication, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05993611 (Phase 1, suspended): Evaluates allogeneic CD6-CAR T regulatory cells (CD6-CAR Tregs) for steroid-refractory/dependent chronic GVHD after alloHCT, with optional tafasitamab-cxix for cell ablation. Interventions and mechanisms: 1) CD6-CAR Tregs (adoptive cellular immunotherapy): donor-derived Tregs engineered with a CAR targeting CD6 to enhance regulatory function, suppress pathogenic T-cell activation/proliferation, reduce proinflammatory cytokines, and promote immune tolerance. 2) Tafasitamab-cxix (Monjuvi, monoclonal antibody, anti-CD19): optionally used post-infusion to ablate transferred CAR Tregs as a safety measure. Targets: CD6 on T cells (co-stimulatory pathway implicated in T-cell activation/trafficking), pathogenic donor effector T cells driving cGVHD, proinflammatory cytokines (IFN-γ, IL-6, TNF-α) and adhesion molecules, CD19 (when tafasitamab is used).