Actively Recruiting
CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-11-25
9
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
1. Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma. 2. To determine the maximum tolerated dose (MTD) of car19-bcma dual target car-t in the treatment of relapsed / refractory multiple myeloma.
CONDITIONS
Official Title
CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent and follow study visits and procedures
- Diagnosed with relapsed or refractory multiple myeloma
- Positive expression of BCMA and/or CD19 in myeloma cells confirmed by flow cytometry or immunohistochemistry
- Received at least one prior treatment including proteasome inhibitors, immunomodulatory drugs, or CD38 monoclonal antibodies, or resistant to these treatments
- Aged 18 to 70 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Estimated survival time longer than 3 months from consent
- Hemoglobin level at least 60 g/L (transfusible)
- Liver, kidney, and cardiopulmonary function within specified limits: creatinine ≤ 2× upper limit of normal; left ventricular ejection fraction ≥ 50%; blood oxygen saturation > 90%; total bilirubin ≤ 1.5× upper limit of normal; ALT and AST ≤ 2.5× upper limit of normal
- Agree to use contraception if planning pregnancy before and for six months after study participation
You will not qualify if you...
- Severe cardiac insufficiency with left ventricular ejection fraction below 50%
- History of severe lung function impairment
- Presence of other advanced malignant tumors
- Serious infections that cannot be effectively controlled
- Severe autoimmune diseases or innate immune deficiencies
- Active hepatitis B or C infection with viral loads above detection limits
- HIV infection, AIDS, or syphilis infection
- Severe allergy history to biological products including antibiotics
- Acute graft-versus-host disease within one month after immunosuppressant withdrawal following allogeneic hematopoietic stem cell transplantation
- Other serious physical or mental illnesses or abnormal lab results increasing study risks or interfering with results
- Pregnant or breastfeeding females with fertility potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
Y
Yan Xu, MD
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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