NCT05346198

Evaluate CART-BCMA in Patients With Relapsed and/or Refractory Multiple Myeloma

A Phase I Clinical Trial to Evaluate CART-BCMA in Patients With Relapsed and/or Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Simnova Biotechnology Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, multicenter, open-label study o evaluate the safety and efficacy of CART-BCMA in subjects with relapsed/refractory multiple myeloma.

Detailed description

The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CART-BCMA to establish a recommended dose (RD); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CART-BCMA at the RD.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	CART-BCMA	The CART-BCMA (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.

Timeline

• Start date: 2021-03-12
• Primary completion: 2022-07-31
• Completion: 2024-12-31
• First posted: 2022-04-26
• Last updated: 2024-02-23

Locations

2 sites across 1 country: China