eligibility_summary
Eligible: advanced/metastatic clear‑cell RCC, prior ICI and VEGF therapy with progression/toxicity, adequate labs, ECOG 0–1, measurable disease, contraception for 12 mo post AB‑2100. Exclude: systemic therapy ≤14 d (≤28 d if antibody) before collection/conditioning, investigational cell tx ≤8 wks, prior anti‑CA9, MI/unstable angina ≤6 mo, pleural effusion needing drainage ≤28 d, active autoimmune disease on immunosuppression or uncontrolled, untreated brain mets, declines extended safety monitoring.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06245915 (Phase 1/2). Intervention: AB-2100, an autologous engineered T-cell therapy (biologic cell therapy) given as a single IV infusion, with optional conditioning chemotherapy. Mechanism: patient T cells are genetically modified with an integrated “logic-gate” circuit to recognize prostate-specific membrane antigen (PSMA) and carbonic anhydrase 9 (CA9), aiming to enhance tumor specificity and reduce off-tumor toxicity, activated cells mediate cytotoxic killing of targeted cancer cells. Targets: tumor-associated antigens PSMA and CA9 expressed in clear-cell renal cell carcinoma. Pathways/cells affected: engineered CAR-like T-cell activation pathways in infused autologous T cells, tumor cells expressing PSMA and/or CA9 are the direct targets. Purpose: assess safety/efficacy and determine the maximum tolerated dose in recurrent advanced/metastatic ccRCC post checkpoint and VEGF therapy.