NCT06614686

U87 CAR-T in Patients With Advanced Head and Neck Tumors

A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.

Detailed description

Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Conditions

• Nasopharynx Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	U87 autologous CAR T-cell	Treatment with U87 chimeric antigen receptor T-cell infusion.

Timeline

• Start date: 2024-09-20
• Primary completion: 2026-10-31
• Completion: 2027-12-31
• First posted: 2024-09-26
• Last updated: 2024-09-26

Locations

1 site across 1 country: China