NCT07085559

Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms.

Detailed description

This is an open-label study. This study is indicated for relapsed or refractory Plasma Cell Neoplasms.The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies. 1. Main research objectives: To evaluate the safety and tolerability of metabolically armed BCMA CAR-T Cells in the treatment of r/r plasma cell neoplasms. 2. Secondary research objectives: (1)To evaluate the pharmacokinetic (PK) and pharmacodynamics (PD) characteristics of metabolically armed BCMA CAR-T cells after infusion. (2) To evaluate tumor remission after infusion of metabolically armed BCMA CAR-T Cells.

Conditions

• Multiple Myeloma (MM)
• Plasma Cell Leukemia (PCL)
• AL Amyloidosis (AL)

Interventions

Type	Name	Description
DRUG	Metabolically Armed BCMA CAR-T cells.	Each subject receive metabolically armed BCMA CAR- T cells by intravenous infusion.

Timeline

• Start date: 2025-06-23
• Primary completion: 2027-06-30
• Completion: 2027-10-15
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: China