Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT04776330

a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-02-25

80

Participants Needed

1

Research Sites

329 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

CONDITIONS

Official Title

a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent
  • Diagnosed with relapsed/refractory multiple myeloma or other plasma cell disease
  • Failed to standard chemotherapy regimens, or relapse after complete remission with high-risk or refractory status, or relapse after hematopoietic stem cell transplantation
  • Evidence of BCMA expression on cell membranes
  • Aged 18 to 75 years
  • Expected survival time above 3 months
  • Karnofsky Performance Status (KPS) greater than 60
  • No serious mental disorders
  • Left ventricular ejection fraction at least 50%
  • Sufficient liver function with ALT/AST less than or equal to 3 times upper limit of normal and bilirubin less than or equal to 2 times upper limit of normal
  • Sufficient kidney function with creatinine clearance less than or equal to 2 times upper limit of normal
  • Sufficient lung function with indoor oxygen saturation at least 92%
  • Able to provide single or venous blood collection and no contraindications to cell collection
  • Able and willing to follow study visit schedule and protocol requirements
Not Eligible

You will not qualify if you...

  • Previous history of other malignancy
  • Presence of uncontrolled active infection
  • Disorders requiring glucocorticoid treatment
  • Active or chronic graft-versus-host disease (GVHD)
  • Treatment with T cell inhibitors
  • Pregnant or breastfeeding women
  • Any condition deemed unsuitable by investigators, including HIV, HCV infection, or intravenous drug addiction that may affect data analysis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

Actively Recruiting

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Research Team

Z

Zhi Yang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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