Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
920th Hospital of Joint Logistics Support Force
Kunming, Yunnan, China
Actively Recruiting
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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