Actively Recruiting
Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With 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
Researchers are evaluating the safety and effectiveness of BCMA-targeted prime CAR-T cell therapy in patients with relapsed or refractory Multiple Myeloma and other plasma cell diseases. This study focuses on patients who have limited treatment options and aims to assess adverse events and disease response after receiving this targeted therapy. Participants will receive a single treatment of BCMA-targeted prime CAR-T cells designed to attack myeloma cells expressing BCMA. The study includes Phase 1 and Phase 2 components and monitors patients for up to two years to evaluate treatment response and safety. During the study, participants will undergo regular assessments including monitoring of adverse events, disease status, levels of BCMA-targeted CAR-T cells in blood and bone marrow, clonal plasma cell quantities, serum IL-6 levels, and survival outcomes. The total follow-up duration for outcome measurement is up to two years to observe treatment effects and patient safety over time.
CONDITIONS
Brief 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 standard chemotherapy regimens, or relapsed after remission or stem cell transplant
- Evidence of BCMA expression on cell membranes
- All genders, aged 18 to 75 years
- Expected survival longer than 3 months
- Karnofsky Performance Scale score above 60
- No serious mental disorders
- Left ventricular ejection fraction at least 50%
- Adequate liver function (ALT/AST ≤ 3 times upper limit normal, bilirubin ≤ 2 times upper limit normal)
- Adequate kidney function (creatinine clearance ≤ 2 times upper limit normal)
- Adequate lung function (indoor oxygen saturation ≥ 92%)
- Eligible for blood cell collection and no contraindications
- Ability and willingness to follow study visits and protocol requirements
You will not qualify if you...
- Previous history of other cancers
- Presence of uncontrolled active infections
- Conditions requiring glucocorticoid treatment
- Active or chronic graft-versus-host disease
- Treatment with T cell inhibitors
- Pregnant or breastfeeding women
- Any condition making participation unsuitable as judged by investigators (e.g., HIV, hepatitis C infection, intravenous drug use)
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 - Duration of treatment until completion as per protocol
Participants receive BCMA targeted prime CAR-T cell therapy as the active treatment for relapsed/refractory Multiple Myeloma or plasma cell disease.
1 baseline visit and multiple follow-up visits during treatment
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes including adverse events and disease status for up to 2 years after treatment.
Regular follow-up visits during the 2-year period
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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