eligibility_summary
Eligible: age 16–90, histology-proven cancer, life expectancy >3 mo, KPS≥60/ECOG 0–2, failed/no standard therapy, ≥1 measurable lesion, tumor/effusion for TILs, adequate counts/coagulation/renal/hepatic function, contraception, off anti-cancer Rx ≥28 d, consent. Exclude: ≥15 mg prednisone/autoimmunity, poor lung or major cardiac disease, HIV/HBV/HCV/syphilis or active infection, prior irAE>G3, pregnancy/lactation, prior organ/allo-SCT/dialysis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase I/II single-arm study in refractory metastatic colorectal cancer testing: 1) Autologous TIL therapy (adoptive cell therapy, ex vivo–expanded tumor-reactive T cells) to recognize patient-specific tumor antigens via TCR and kill cancer cells. 2) Pembrolizumab (anti–PD-1 IgG4 monoclonal antibody, checkpoint inhibitor) to block PD-1 and reverse T-cell exhaustion. 3) Aldesleukin/IL-2 (recombinant cytokine) to expand/activate infused T cells. Preconditioning: cyclophosphamide (alkylating chemotherapy) and fludarabine (purine analog) for non-myeloablative lymphodepletion to reduce Tregs/host lymphocytes and promote engraftment. Targets/pathways: tumor-reactive CD8+/CD4+ T cells, PD-1/PD-L1 inhibitory axis, IL-2 receptor signaling, indirect modulation of the tumor microenvironment by depleting suppressive cells and creating homeostatic cytokine space (IL-7/IL-15). Primary endpoint: ORR.