NCT05302648

To Evaluate the Safety and Efficacy of Human Derived Anti-BCMA CAR-T Injection for Subjects with R/R MM

A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human Derived Anti-BCMA CAR-T Injection for Subjects with Relapsed/Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hrain Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human Derived anti-BCMA CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma.

Detailed description

Subjects withe relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility including disease assessments, a physical exam, Electrocardiograph, Computed tomography（CT）/Magnetic Resonance Imaging(MRI)/Positron Emission Tomography（PET）,liver/renal function tests, complete blood count with differential and complete metabolic profile and etc.. Subjects will receive precondtioning chemotherapy prior to the infusion of BCMA CAR- T cells. After the infusion, subjects will be followed for adverse events pharmacokinetic/pharmacodynamics characteristics, efficacy, of BCMA CAR-T cells. Study procedures may be performed while hospitalized.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Human Derived anti-BCMA CAR-T Injection	Autologous genetically modified anti-BCMA CAR transduced T cells

Timeline

• Start date: 2022-02-09
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2022-03-31
• Last updated: 2025-01-03

Locations

1 site across 1 country: China