Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM
NCT ID: NCT03706547
Last Updated: 2018-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2018-10-30
2021-12-31
Brief Summary
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Detailed Description
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1\. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.
Secondary Objectives
1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.
2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anti-CD19/BCMA CAR-T cells
1. Chemotherapy with a classic combination with fludarabine and cyclophosphamide;
2. Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.
anti-CD19/BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
Interventions
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anti-CD19/BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)
* Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma
* Exited measurable lesions and in accordance with one of the following test indicators: serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy
* The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days
* At least 90 days after stem cell transplantation
* Clinical performance status of ECOG score 0-2
* Creatinine≤2.0 mg/dl
* Bilirubin≤2.0 mg/dl
* The ALT/AST value is lower than 2.5-fold of normal value
* Accessible to intravenous injection, and no white blood cell collection contraindications
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom
* 5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion
* Able to understand and sign the Informed Consent Document.
Exclusion Criteria
* Patients with second malignancies in addition to multiple myeloma
* Active hepatitis B or C, HIV infections
* Any other active diseases could affect the enrollment of this trial
* Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
* Patients with organ failure
* Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
* A history of mental illness and poorly controlled
* Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
* Patients who are accounted by researchers to be not appropriate for this test
* Subjects suffering disease affects the understanding of informed consent or complying with study protocol
18 Years
70 Years
ALL
No
Sponsors
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Hrain Biotechnology
UNKNOWN
Shanghai East Hospital
OTHER
Peng Liu
OTHER
Responsible Party
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Peng Liu
Professor
Principal Investigators
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Peng Liu, M.D. & Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Department of Hematology ,Fudan University Zhongshan Hospital
Shanghai, , China
Countries
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Central Contacts
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References
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Other Identifiers
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SHZS-MM002
Identifier Type: -
Identifier Source: org_study_id
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