Actively Recruiting
Novel CD19/BCMA Dual-Targeted CAR-T Cell Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-22
25
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
T
Tongji Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma.
CONDITIONS
Official Title
Novel CD19/BCMA Dual-Targeted CAR-T Cell Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory multiple myeloma
- Bone marrow samples show plasma cell membrane BCMA expression of 30% or more
- No response or disease progression after 3 cycles of bortezomib or lenalidomide therapy
- Interval between last treatment and disease progression is more than 30 days
- No current indication for stem cell transplant or patient refuses transplant
- Meets disease progression criteria per 2021 International Myeloma Working Group
- Expected survival greater than 12 weeks
- Disease status measurable by specific protein levels or bone marrow plasma cell percentage
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate venous access for apheresis or blood collection
- White blood cells count 1.5 x 10^9/L or higher
- Platelets count 45 x 10^9/L or higher
- Serum creatinine less than or equal to 1.5 times upper limit of normal
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 times upper limit of normal
- Laboratory values must be stable without ongoing supportive therapy
You will not qualify if you...
- Received systemic therapy like cyclophosphamide or fludarabine within 2 weeks before enrollment
- Prior CD19/BCMA CAR-T therapy or cell/bispecific antibody therapy within 8 weeks before treatment
- Received bendamustine-containing regimens within 6 months before treatment
- Positive for hepatitis C virus (HCV) or HIV
- Any uncontrolled active infection including active tuberculosis or high Hepatitis B virus DNA levels
- Active infection within 72 hours before treatment
- Current use of systemic cyclosporine or steroids like dexamethasone
- Renal impairment with serum creatinine over 1.5 times upper limit of normal
- Liver impairment with AST or ALT over 2.5 times upper limit of normal and direct bilirubin over 1.5 times upper limit
- Low sodium levels below 125 mmol/L
- Low potassium levels below 3.5 mmol/L unless corrected before enrollment
- Pregnant or breastfeeding women
- Other serious health conditions that may affect participation, such as severe heart or central nervous system disorders, recent myocardial infarction, unstable angina, gastric ulcer, or active autoimmune disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuzhao Zhang
Hangzhou, China, 310003
Actively Recruiting
Research Team
X
Xuzhao Zhang
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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