eligibility_summary
Adults ≥18 with unresectable/metastatic HLA‑G+ solid tumors, measurable disease, ECOG 0–1, >12‑wk life expectancy, and adequate organ function. Phase 2a: ccRCC after CPI+TKI, epithelial ovarian after platinum (PARP if BRCA+), or other HLA‑G+ tumors after ≥1 line. Exclude active/untreated CNS disease, major cardiac/lung/autoimmune/immunosuppression/infections, prior CAR‑T, chronic steroids/immunotherapy, recent trial/surgery/live vaccine, pregnancy, contraception required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 1/2a, single‑arm trial in adults with previously treated, advanced HLA‑G–positive solid tumors. Interventions: IVS‑3001, an autologous, genetically engineered anti‑HLA‑G CAR‑T cell therapy (single IV infusion) that redirects patient T cells to recognize HLA‑G on tumor cells and kill them, aiming to overcome HLA‑G–mediated immune evasion, lymphodepletion with fludarabine phosphate (purine‑analog antimetabolite) and cyclophosphamide (alkylating agent) to promote CAR‑T expansion, leukapheresis for T‑cell collection. Targets: HLA‑G–expressing tumor cells and the HLA‑G immune‑evasion pathway (nonclassical MHC‑I). Indications include clear‑cell renal cell carcinoma, epithelial ovarian cancer, and other HLA‑G+ tumors.