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Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03196414
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: CART-138/BCMA/19/more Phase 1 Phase 2

Detailed Description:

Adults ages 18-75 with Relapsed and/or Chemotherapy Refractory Multiple Myelomas.

Design:

Participants may be screened with:

Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Lymphocytes are collected by apheresis from the enrolled patient or a healthy donor. Blood is removed through a needle in an arm. The rest of the blood is returned through a needle in the other arm.

The cells will be changed in a laboratory. Participants will get 2 chemotherapy drugs over 5 days. Two days later, participants will get an intravenous (IV) catheter in an arm. They will get the split doses CART cells on day0, day1, day2 through the IV in 1 infusion.

After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.

Participants will visit the clinic at 1, 2, 3, 6, 9 and 12 months after the infusion, then every 6 months until two years after infusion. A bone marrow sample will be taken at the 3-month visit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
Study Start Date : September 2016
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: CART-138/BCMA/19/more Biological: 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


Outcome Measures
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Primary Outcome Measures :
  1. Determine if there is grade 3 to 5 cytokine release syndrome [ Time Frame: 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


Secondary Outcome Measures :
  1. Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research. [ Time Frame: up to 24 weeks ]
    Number of Patients achieved major reaction rate (MRR;PR+VGPR+CR) According to IMWG response criteria at the end of the research.


Other Outcome Measures:
  1. Investigators try to test CART 138 cells copies in vivo. [ Time Frame: 2 years ]
    CART Cell survival time by testing CART-138/BCMA cells copies in vivo through PCR Method.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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℃)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196414


Contacts
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Contact: Ling zhi Yan, PhD 13584821140 yanlingzhi@suda.edu.cn

Locations
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China, Jiangsu
First Affiliated Hospital, Soochow University Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Ling zhi Yan, Phd    13584821140    yanlingzhi@suda.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
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Principal Investigator: Fu cheng cheng, PhD First Affiliated Hospital,Soochow University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03196414    
Other Study ID Numbers: myeloma-01
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases