Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
NCT ID: NCT04194931
Last Updated: 2019-12-11
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
2019-12-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mixed BCMA/CD19 CAR-T Transfer
Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts
Autologous BCMA CAR-T cells and CD19 CAR-T cells
Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5\*10\^6 cells/kg body weight,separately.
Interventions
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Autologous BCMA CAR-T cells and CD19 CAR-T cells
Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5\*10\^6 cells/kg body weight,separately.
Eligibility Criteria
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Inclusion Criteria
2. Estimated Survival time \> 12 weeks
3. Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
4. Chemotherapy failure or recurrent multiple myeloma
5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level
6. Bilirubin\<2.0mg/dl
7. Karnofsky Performance Status\>50% at the time of screening
8. Adequate pulmonary, renal, hepatic, and cardiac function
9. Fail in autologous haemopoietic stem cell transplantation
10. Not suitable for stem cell transplantation conditions or abandoned due to conditions
11. Free of leukocytes removal contraindications
12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent
Exclusion Criteria
2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
3. The patient is an active hepatitis B or hepatitis C infection
4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
5. Abnormal vital signs
6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
8. General infection or local severe infection, or other infection that is not controlled
9. Dysfunction in lung, heart, kidney and brain
10. Severe autoimmune diseases
11. Other symptoms that are not applicable for CAR-T
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Nanchang University
OTHER
Responsible Party
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LiFei,M.D., Ph.D.
M.D.,Ph.D.
Locations
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The First Affiliated Hospital of Nangchang University
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Fei LI, M.D., Ph.D.
Role: primary
Other Identifiers
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2018028
Identifier Type: -
Identifier Source: org_study_id