NCT05583201

NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors

A Single-center, Open-label, Single-arm Clinical Study of the Safety and Efficacy of KD-496 CAR-T Therapy in Advanced NKG2DL+/CLDN18.2+ Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: jianming xu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.

Detailed description

This is an open-label, dose escalation/expansion study to assess the safety,tolerability, and efficacy of KD-496 cell infusion in patients with advanced NKG2DL+/CLDN18.2+ solid tumors. In this study, the enrollment of the patients must meet the inclusion and exclusion criteria. All subjects will be undergo screening, pre-treatment (cell product preparation, lymphodepleting chemotherapy), treatment and follow up.

Conditions

• Gastric Cancer
• Pancreatic Cancer
• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	KD-496	Autologous genetically modified anti-NKG2DL/CLDN18.2 CAR transduced T cells

Timeline

• Start date: 2022-10-13
• Primary completion: 2024-06-01
• Completion: 2026-06-01
• First posted: 2022-10-17
• Last updated: 2023-02-08

Locations

1 site across 1 country: China