Actively Recruiting
Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
Led by The First Affiliated Hospital of Soochow University · Updated on 2019-05-02
10
Participants Needed
1
Research Sites
534 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).
CONDITIONS
Official Title
Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CD138 or BCMA antigen positive multiple myeloma with no curative treatment options available
- Relapsed and/or refractory multiple myeloma
- Relapsed after prior autologous or allogeneic stem cell transplant
- Expected survival of at least 3 months
- Creatinine level less than 2.0 mg/dl
- Blood coagulation tests (PT and APTT) less than twice normal
- Arterial blood oxygen saturation greater than 92%
- Liver enzymes (ALT/AST) less than three times normal
- Karnofsky score of 60 or higher and ECOG score 2 or less
- Adequate vein access for apheresis with no other leukapheresis contraindications
- No systemic chemotherapy within one month prior to infusion
- No immunotherapy within three months prior to infusion
- Provided voluntary informed consent
You will not qualify if you...
- Pregnant or lactating women
- Uncontrolled active infection
- Active hepatitis B or C infection
- Current use of systemic steroids (inhaled steroids allowed)
- Previous treatment with any gene therapy products
- Uncontrolled active medical disorders preventing participation
- HIV infection
- History of heart attack or severe arrhythmia within six months
- Any form of primary immunodeficiency such as Severe Combined Immunodeficiency Disease
- Fever of unknown cause with temperature above 38°C
AI-Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
L
Ling zhi Yan, PhD
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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