eligibility_summary
Include: Adults 18–75 with TP53 R248Q‑mutated solid tumors (lung/CRC/pancreas or others post‑standard), ECOG 0–1, ≥12‑wk survival, measurable disease (RECIST/mRECIST), ≤3 asymptomatic brain mets <3 cm, adequate organ function. Exclude: prior transplant, active HBV/HCV/HIV/syphilis, prior cell/TP53 drugs, recent anti‑cancer therapy/surgery/live vaccine, unresolved AEs, chronic steroids, infection/autoimmune/ILD, uncontrolled effusions, serious CV/QTc/HTN, pregnant/lactating, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: Autologous, gene-engineered TCR-T cell therapy (biologic). Patient T cells are transduced with a T-cell receptor specific for the TP53 R248Q mutant peptide presented by HLA-A11:01 and reinfused (dose-escalation, multiple infusions per cycle). Mechanism of action: The introduced TCR enables tumor-specific recognition of the TP53 R248Q neoantigen in the context of HLA-A11:01, triggering TCR signaling and CD8+ T-cell cytotoxicity (perforin/granzyme release and cytokine-mediated killing) against cancer cells. Targets (cells/pathways): Tumor cells in advanced solid tumors (e.g., lung adenocarcinoma, colorectal, pancreatic) that harbor the TP53 R248Q mutation and present it on MHC class I HLA-A11:01, pathways include p53-mutant neoantigen presentation and TCR/MHC-I mediated immune killing. Purpose: Evaluate safety and preliminary efficacy in HLA-A11:01+, TP53 R248Q–positive solid tumors.