Actively Recruiting
A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2024-12-13
12
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.
CONDITIONS
Official 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 before any study evaluations
- Aged between 18 and 75 years
- Expected survival of at least 12 weeks
- ECOG performance status of 2 or less
- Positive bone marrow flow cytometry for BCMA antigen
- Diagnosis of multiple myeloma with measurable lesions per IMWG criteria, including specific levels of serum M protein, urinary M-protein, serum free light chain, or plasma cell counts
- Received and failed at least three different treatment mechanisms, with relapse or treatment difficulties as defined
- No significant lung function abnormalities and oxygen saturation above 92% without oxygen
- Blood biochemistry within specified limits (AST/ALT, bilirubin, creatinine clearance, lipase, amylase)
- Blood counts meeting specified minimum levels for lymphocytes, neutrophils, hemoglobin, and platelets
- Men with fertility and women of childbearing age agree to use effective contraception from consent signing until 2 years after study drug use; negative pregnancy test for women of childbearing age at screening
You will not qualify if you...
- Asymptomatic (smoldering) multiple myeloma
- Multiple myeloma with only extramedullary lesions
- Plasma cell leukemia
- Amyloidosis
- Central nervous system metastasis, leptomeningeal disease, or metastatic spinal cord compression
- Pregnancy or breastfeeding
- Positive for hepatitis B surface antigen or core antibody unless very low viral load; positive hepatitis C antibodies and RNA; HIV antibody positive; positive syphilis or cytomegalovirus tests
- Significant cardiovascular diseases including prolonged QT interval, heart failure above NYHA Grade II, reduced left ventricular ejection fraction (≤50%), poorly controlled hypertension, or significant arrhythmias
- Unstable angina or acute myocardial infarction within 6 months prior to consent
- Previous anti-CD45 or anti-CD3 treatment
- Allergies to study drug components including cyclophosphamide or fludarabine
- Use of investigational or systemic anti-tumor treatment within 4 weeks before cell collection
- History of other primary cancers within 5 years except fully treated cervical carcinoma in situ or localized skin cancers
- Active uncontrolled infections needing parenteral treatment within 4 weeks prior to collection
- History of active pulmonary tuberculosis within 1 year unless no current evidence
- History or presence of interstitial lung disease or pneumonia
- Autologous stem cell transplant within 8 weeks prior or planned during study
- Prior allogeneic stem cell therapy
- Any condition affecting compliance or suitability for the study as judged 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
China, Shanghai Mengchao Cancer Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jinxing Lou
CONTACT
J
Jinxing Lou
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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