The First Affiliated Hospital of Soochow University
Phase
Phase 1/2
Started
2016-09
Last updated
2019-05-02
Condition(s) studied
Multiple Myeloma
Investigational drug(s) / intervention(s)
CART-138/BCMA/19/more
CART-138/BCMA/19/more: Cyclophosphamide，Fludarabine，CART-138/BCMA /19/more cells Cyclophosphamide: 300 mg/m2 IV over 30 minutes on days -5 , -4,and -3; Fludarabine: 30 mg/m2 IV over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Biological: Anti-CD138/BCMA/CD19/more total CART cells 5x106- 100x106 CAR+ T cells per kg of recipient bodyweight
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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 Criteria:
* Pregnant or lactating women
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previously treatment with any gene therapy products
* 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).
* Patients with fever of unknown origin (T \> 38℃)
Primary outcome measure(s)
Determine if there is grade 3 to 5 cytokine release syndrome — 2 weeks-12 months after initial dose Number of Patients With Grade 3 Through Grade 5 Cytokine Release Syndrome(CRS) That Are Related to Study Intervening Measures, Graded According to NCI CTCAE Version 4.0
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital, Soochow University
Suzhou
Jiangsu
Recruiting
More The First Affiliated Hospital of Soochow University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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