NCT04500431

Clinical Study to Evaluate the Safety and Feasibility of spCART-269 Injection in the Treatment of MM

Clinical Study to Evaluate the Safety and Feasibility of Targeting CD269 Chimeric Antigen Receptor Engineered T Cell (spCART-269) Injection in the Treatment of CD269-positive Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or refractory multiple myeloma patients.

Detailed description

This study plans to enroll 10 patients to assess the safety and efficacy of spCART-269. Subjects who meet the eligibility criteria will receive a single dose of spCART-269 injection. The study will include the following sequential phases: Screening, Pre-treatment (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Targeting CD269 chimeric antigen receptor engineered T cells	Targeting CD269 chimeric antigen receptor engineered T cells, single infusion intravenously

Timeline

• Start date: 2018-07-01
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2020-08-05
• Last updated: 2020-08-05

Locations

1 site across 1 country: China