NCT05605197

U87 CART in Treatment of Advanced Solid Tumor

Clinical Study to Evaluate the Safety and Efficacy of U87 CART in Treatment of Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .

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

• Pancreatic Cancer
• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	U87 CAR-T	Subjects will be pretreated with cyclophosphamide 250\~500 mg/m2( body surface area) for 3 days prior to Intravenous injection of U87, followed by intraartery of U87 14 days later with intravenous IL-2. Researchers can perform intratumoral injection based on their judgment.This study will explore two dose of dose 1 (DL-1): 1×106 (±20%) to dose 2 (DL-2): 1×107 (±20%),each group was enrolled in 3\~6 patients.

Timeline

• Start date: 2022-10-19
• Primary completion: 2024-12-31
• Completion: 2025-10-08
• First posted: 2022-11-04
• Last updated: 2024-05-28

Locations

1 site across 1 country: China