Actively Recruiting
A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed/Refractory Multiple Myeloma
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2024-12-13
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new type of cell therapy called autologous chimeric antigen receptor T (CAR-T) cells that target CD19, CD22, and BCMA in patients with relapsed or refractory multiple myeloma. This early-phase, open-label study aims to assess the safety and tolerability of this treatment and to find the highest dose that patients can safely receive. Additional goals include studying how the therapy behaves in the body, how long the CAR-T cells survive, and its effects on the disease. Participants will go through several phases including screening, collection of their immune cells (apheresis), a treatment to prepare their body (lymphodepletion), followed by a single intravenous infusion of the CAR-T cells. After the infusion, patients will be closely monitored for dose-limiting toxicities during the first 28 days and followed up for longer-term observations. The study uses a dose escalation approach to find the maximum tolerated dose. During the study, participants will have multiple assessments such as blood tests to measure the concentration and activity of CAR-T cells, immune markers, and signs of disease progression. Researchers will also track overall survival and progression-free survival over two years. Safety and response will be evaluated frequently from the day of infusion through follow-up visits. The total participation duration may extend up to the end of the study, which is expected in late 2027.
CONDITIONS
Brief Title
A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign an informed consent form
- Age between 18 and 75 years old
- Expected to survive at least 12 weeks
- ECOG score of 2 or less
- Positive BCMA antigen in bone marrow flow cytometry
- Diagnosed with measurable multiple myeloma according to IMWG criteria
- Previously treated with at least three different mechanisms of action but failed, relapsed, or intolerant to last treatment
- Lung function normal with oxygen saturation over 92% without oxygen support
- Liver function tests within specified limits
- Kidney function with creatinine clearance rate at least 30 mL/min
- Blood counts meeting specified thresholds for lymphocytes, neutrophils, hemoglobin, and platelets
- Men and women of childbearing potential agree to use effective contraception during and for 2 years after treatment
You will not qualify if you...
- Asymptomatic multiple myeloma
- Multiple myeloma with only extramedullary lesions
- Plasma cell leukemia
- Amyloidosis
- CNS metastasis or leptomeningeal disease
- Pregnancy or breastfeeding
- Positive for hepatitis B, C, HIV, syphilis, or CMV without controlled viral load
- Significant cardiovascular disease including prolonged QT interval, heart failure, low ejection fraction, uncontrolled hypertension, or serious arrhythmias
- Recent unstable angina or heart attack within 6 months
- Previous anti-CD45 or anti-CD3 treatments
- Allergy to study drugs including cyclophosphamide or fludarabine
- Recent investigational drug or anti-tumor treatment within 4 weeks
- History of other cancers within 5 years except certain skin or cervical cancers
- Active infections requiring treatment within 4 weeks
- History of active pulmonary tuberculosis within 1 year
- Interstitial lung disease or pneumonia
- Recent or planned autologous stem cell transplant within 8 weeks
- Previous allogeneic stem cell therapy
- Any condition affecting compliance or suitability for the study
AI-Screening
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Your Study Journey
Duration - 10 to 30 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 to 2 days
Participants undergo leukapheresis to isolate cells for CAR-T therapy production.
1 visit (in-person)
Duration - 3 days
Participants receive lymphodepletion chemotherapy prior to CAR-T cell infusion.
3 visits (in-person, daily)
Duration - 1 day
Participants receive one intravenous infusion of CD19/CD22/BCMA CAR-T cells.
1 infusion visit (in-person)
Duration - 28 days
Participants are closely monitored for safety and tolerability following CAR-T infusion.
Multiple visits for assessments during this period
Duration - Up to study completion (several months to years)
Participants are followed for long-term safety, survival, and disease progression monitoring.
Regular follow-up visits scheduled up to 24 months
Trial Site Locations
Total: 1 location
1
China, Shanghai Mengchao Cancer Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jinxing Lou
J
Jinxing Lou
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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