Actively Recruiting
Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of R/RMM
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-07-16
60
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
To explore the safety and efficacy of nanobody-based BCMA-targeting biepitope CAR-T cells in the treatment of relapsed/refractory multiple myeloma，this study will be conducted in multiple study centers, with 60 patients openly enrolled to receive CAR-T cell therapy. Patients participating in clinical trials will be tested and evaluated for treatment safety, efficacy, duration of response, and long-term survival.
CONDITIONS
Official Title
Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of R/RMM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legal guardian voluntarily consents to participate
- Age 18 to 75 years
- Diagnosed with multiple myeloma per international standards (IMWG 2014)
- Relapsed, refractory, or primary refractory disease after at least three prior therapies
- BCMA expression confirmed by flow cytometry or immunohistochemistry
- No antibody-based drug treatment within 2 weeks prior to therapy
- ECOG performance status 0 to 2
- Hemoglobin 70 g/L and platelet count 30 x 10^9/L
- Adequate liver, kidney, and cardiopulmonary function including serum creatinine 1.5x ULN or creatinine clearance >30 ml/min, LVEF 50%, peripheral oxygen saturation >90%, total bilirubin 1.5x ULN, ALT and AST 2.5x ULN
You will not qualify if you...
- Other malignancies diagnosed or treated within past 3 years
- Cardiac conditions including atrial fibrillation, recent myocardial infarction, prolonged QT syndrome, reduced LVSF <30% or LVEF <50%, significant pericardial effusion, or NYHA class III/IV heart failure
- Active graft-versus-host disease
- History of severe pulmonary disease
- Advanced stage other malignant tumors
- Severe or uncontrolled infections
- Severe autoimmune diseases or congenital immunodeficiency
- Active hepatitis B or C infection with abnormal liver function
- HIV or syphilis infection
- Severe allergy to biological products
- Central nervous system disorders such as uncontrolled epilepsy or dementia
- Pregnancy or breastfeeding
- Fertility plans within 12 months after CAR-T infusion
- Any other condition deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
M
Mei Heng, M.D., Ph.D
CONTACT
Y
Yun Kang
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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