Actively Recruiting
BCMA-Targeted CAR-T Cell Therapy for 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of BCMA-targeted CAR-T cell therapy in patients with relapsed or refractory Multiple Myeloma and plasma cell diseases. The study addresses the limited treatment options available for these conditions by focusing on BCMA, a marker found on most Multiple Myeloma cells, as a target for the CAR-T therapy. The main goal is to assess both the safety and the response of patients to this treatment approach. Participants in this single-arm study will receive BCMA CAR-T cell therapy. The treatment involves administering CAR-T cells that target BCMA to patients who have relapsed or refractory Multiple Myeloma. The study includes a follow-up period to monitor treatment effects and side effects over two years, including assessments of how the CAR-T cells persist in the body and their impact on disease markers. Throughout the study, participants will be closely monitored with regular assessments, including measuring adverse events related to treatment, response rates, levels of CAR-T cells in blood and bone marrow, plasma cell counts, cytokine levels, and survival outcomes such as progression-free and overall survival. The study expects participants to adhere to scheduled visits and protocol requirements for up to two years to fully evaluate the treatment's impact and safety profile.
CONDITIONS
Brief Title
BCMA-Targeted CAR-T Cell Therapy for 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 or refractory multiple myeloma or other plasma cell disease
- Failed standard chemotherapy regimens, relapsed after remission, or relapsed after stem cell transplantation
- Evidence of BCMA expression on cell membranes
- All genders, aged between 18 and 75 years
- Expected survival time over 3 months
- Karnofsky Performance Status (KPS) greater than 60
- No serious mental disorders
- Left ventricular ejection fraction 50% or higher
- Adequate liver function (ALT/AST ≤3 times upper limit of normal and bilirubin ≤2 times upper limit)
- Adequate kidney function (creatinine clearance ≤2 times upper limit)
- Adequate lung function (oxygen saturation ≥92%)
- Able to undergo blood collection with no contraindications
- Willing and able to follow study visit schedule and protocol requirements
You will not qualify if you...
- Previous history of other malignancies
- 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
- Conditions unsuitable for study participation, such as HIV, hepatitis C infection, or intravenous drug addiction
- Any situation judged by investigators as not suitable for participation or that may affect data analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive BCMA CAR-T cell therapy to target their relapsed or refractory multiple myeloma or plasma cell disease.
Initial treatment visit followed by regular monitoring visits during treatment
Duration - Up to 2 years
Participants are monitored for safety, treatment response, and long-term outcomes after receiving BCMA CAR-T cell therapy.
Regular follow-up visits for up to 2 years post-treatment
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
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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