Tests engineered T cells against multiple myeloma that returned or stopped responding
Tests modified immune T cells in adults with relapsed or chemotherapy-resistant multiple myeloma.
Plain-language title generated from the registry record
Registry title: Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT03196414, who can take part
Where in China
- First Affiliated Hospital SooChow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT03196414
- Record updated
- 2 May 2019
- Original description
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).Read full original descriptionShow less
Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
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).
Inclusion: CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT); Relapsed and/or refractory multiple myeloma; Relapsed after prior autologous or allogenic SCT; Expected survival ≥ 3 months; Creatinine < 2.0 mg/dl; Blood coagulation function: PT and APTT < 2x normal; Arterial blood oxygen saturation > 92%; Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) < 3x normal; Karnofsky scores ≥ 60 and ECOG score ≤ 2; Adequate venous access for apheresis, and no other contraindications for leukapheresis; Patients should not take system chemotherapy in one month and immunotherapy in three months prior to CART cells infusion; Voluntary informed consent is given.
Exclusion: Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary; Previously treatment with any gene therapy products; Uncontrolled active infection; Active hepatitis B or hepatitis C infection; Any uncontrolled active medical disorder that would preclude participation as outlined; HIV infection; History of myocardial infarction and severe arrhythmia in half a year; Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease); Pregnant or lactating women; Patients with fever of unknown origin (T > 38℃).