A Phase 1, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors

Study Summary

This is an open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CIB in vivo CAR-T lentiviral injection in patients with advanced malignant tumors. The study will enroll patients with histologically or cytologically confirmed advanced solid tumors that have progressed on or are intolerant to standard therapies. A "3+3" dose-escalation design will be used, with planned dose levels including 1×10⁵ TU/kg, 3×10⁵ TU/kg, 1×10⁶ TU/kg, 3×10⁶ TU/kg, 1×10⁷ TU/kg, and 3×10⁷ TU/kg. The primary objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) based on dose-limiting toxicities (DLTs) observed within 28 days after administration. Secondary objectives include evaluating adverse events, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic parameters of the study drug.

Interventions

Study Locations

Official Trial Information