eligibility_summary
Adults ≥18. Phase I: any solid tumor, PD‑L1 ≥1%, ≥2 prior therapies, Phase IIa: TNBC/NSCLC/CRC/GBM, PD‑L1 ≥1%, ≥2 prior. Require measurable disease (RECIST/RANO), ECOG ≤1, life expectancy >12 wks, recovery to ≤G2, adequate renal/hepatic/coag/hematologic function. Exclude prior allogeneic cell therapy, hypersensitivity, multiple active cancers, infection, recent steroids/immunosuppressants, HIV, significant CV/autoimmune/psychiatric or other CNS disease (except GBM/stroke), recent trials/chemo/RT, no MRI/CT, pregnancy/lactation or inadequate contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: CAR001 (HLA‑G‑CAR.BiTE allogeneic γδ T cells), a biological cellular immunotherapy. Mechanism of action: donor-derived γδ T cells are engineered to express a CAR that recognizes HLA‑G on tumor cells and to secrete a bispecific T‑cell engager (BiTE) that binds CD3 on endogenous T cells, recruiting and activating bystander T cells for additional tumor killing. γδ T cells provide MHC‑independent tumor recognition with low GVHD risk. Cells/pathways targeted: tumor-expressed HLA‑G (an immune‑evasion molecule), CD3 on host αβ T cells (via BiTE), and γδ T‑cell effector pathways (perforin/granzyme cytotoxicity and cytokine release). Indications under study: relapsed/refractory PD‑L1+ solid tumors with expansion in NSCLC, TNBC, CRC, and GBM.