eligibility_summary
Eligible: adults ≥18, ECOG 0–1 or KPS ≥70, ≥12‑wk life expectancy, adequate organs, off steroids ≥2 wks/5 half‑lives, WOCBP neg, contraception, consent. Exclude: recent anticancer therapy or unresolved AEs, Burkitt, allo‑HSCT <6 mo or severe GVHD, immunodeficiency or autoimmune on immunosuppression, recent vaccine/trial, significant lung disease, other active malignancy, HIV or active HBV/HCV, serious infection or major cardiac/pulm/psych disease, CNS disease/lymphoma, recent DVT/PE, likely noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: PRGN-3007 UltraCAR-T (autologous gene-modified T-cell therapy), fludarabine and cyclophosphamide for lymphodepletion. Mechanisms: PRGN-3007 T cells are engineered with the Sleeping Beauty transposon to co-express (1) a ROR1-targeted chimeric antigen receptor (CAR) to recognize/kill ROR1+ tumor cells, (2) membrane-bound IL-15 to enhance T-cell survival/expansion, (3) an EGFRt/HER1t safety kill switch for conditional elimination, and (4) intrinsic PD-1 downregulation to resist PD-1/PD-L1 checkpoint suppression. Fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) deplete host lymphocytes to aid CAR-T engraftment. Targets/pathways: ROR1 on CLL, MCL, ALL, DLBCL, and TNBC, T-cell activation/cytotoxicity, IL-15 signaling, PD-1 checkpoint, host lymphocyte compartment via lymphodepletion.