eligibility_summary
Inclusion: ≥18, metastatic CRC, measurable, exhausted/unsuitable SOC, ECOG 0–1, life expectancy ≥6 mo (≥3 mo at pTTL), adequate labs, contraception, fit for biopsy/surgery, RLN site not irradiated. Exclusion: recent major CV events, NYHA III–IV, significant lung disease, risk immunodef/autoimmunity, systemic immunosuppression, unresolved ≥G3 irAEs, HBV/HCV/syphilis/HIV, pregnancy, surgery infeasible. Washouts: 4w systemic tx/major surgery/other trials/live vaccines, 2w RT, 3w minor surgery.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: pTTL (personal tumor-trained lymphocytes), an autologous adoptive T‑cell therapy (ATMP). Source cells are tumor‑draining regional lymph node T cells, activated and expanded ex vivo with patient‑specific neoantigen proteins (selected by NGS/PIOR, up to 36 epitopes presented via NAG‑coupled beads), then infused once IV. Mechanism of action: Polyclonal, neoantigen‑specific TCR recognition of tumor peptides on MHC, increasing tumor‑reactive T‑cell numbers and function and overcoming tumor‑induced tolerance to kill CRC cells. Preconditioning: fludarabine (purine analog) and cyclophosphamide (alkylator) for lymphodepletion to enhance engraftment and activity. Targets: autologous CD8+ and CD4+ T cells, tumor cells displaying personalized neoantigens, pathways include TCR signaling, antigen presentation (MHC I/II), and cytotoxic effector mechanisms (perforin/granzyme).