NCT05775666

UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors

Exploratory Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of UCLM802 (Anti-Mesothelin CAR-T) cell injection in patients with Mesothelin-positive advanced malignant solid tumors.

Detailed description

This study will include two parts, dose escalation phase (accelerated titration and 3+3 design) followed by a dose expansion phase (Cohort 1: Malignant mesothelioma; Cohort 2: Advanced malignant tumors of the digestive system; Cohort 3: Other advanced malignant solid tumors.). All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by UCLM802 cell injection. The dose escalation phase will determine the maximum tolerated dose (MTD) of UCLM802 cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of UCLM802 cell injection, and establish recommended phase 2 dose (RP2D).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	UCLM802 Cell Injection	Anti-mesothelin CAR-T cells are autologous genetically modified T cells. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by UCLM802 cell injection.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-05-01
• Completion: 2025-01-01
• First posted: 2023-03-20
• Last updated: 2023-03-20