NCT05976906

Universal Dual-target NKG2D-NKp44 CAR-T Cells in Advanced Solid Tumors

A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacodynamics and Immunogenicity of Universal CNK-UT Cells in Patients With Advanced Solid Tumors.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, multi-center, phase I study to evaluate the safety, tolerability, preliminary efficacy, pharmacodynamics and immunogenicity of universal chimeric natural killer receptor modified T-cells (CNK-UT) targeting NKG2D-Ligands and NCR2-Ligands with or without lymphodepletion in advanced solid tumors.

Detailed description

This is a single arm, open-label, multi-center, phase I, dose escalation/indications expansion study to assess the safety and tolerability of CNK-UT cells therapy, and to obtain the preliminary efficacy, pharmacodynamics and immunogenicity result in participants who have been diagnosed with advanced solid tumors and failed to standard systemic treatment.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Universal Chimeric Natural Killer Receptor Modified T-cells (CNK-UT)	1. Dose Escalation: After enrollment, participants will recieve preconditioning by lymphodepletion or not, and then will be treated with CNK-UT cells with a "3 +3" design to determine the maximum tolerated dose. 3 dose level of CNK-UK cells will be tested: 4.6E6/kg，1.5E7/kg，4.6E7/kg. The participants will first receive a single ascending dose(SAD) mode of administration. During the DLT observation period (21 days), if the participants do not experience DLT, they will receive a multiple ascending dose(MAD) mode of administration. 2. Indications Expansion: It will be carried out after all participants have completed the DLT observation in the Dose Escalation phase. The target population, dosage and frequency of drug administration in the indication expansion stage can be adjusted and determined according to the previous research results.

Timeline

• Start date: 2023-05-23
• Primary completion: 2025-05-01
• Completion: 2025-09-01
• First posted: 2023-08-04
• Last updated: 2023-08-04

Locations

1 site across 1 country: China