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Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03271632
Recruitment Status : Unknown
Verified September 2019 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was:  Recruiting
First Posted : September 5, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Study Description
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Brief Summary:
The aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: CAR T cells Phase 1 Phase 2

Detailed Description:
Multiple myeloma (MM) is a malignancy of plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT). This trial is to test the safety and efficacy of T cells genetically modified to specifically target several MM surface antigens, including BCMA, CD38, CD56, CD138 or alternative MM surface antigens, based on a multi-CAR T cell immunotherapy approach. Another goal of the study is to investigate the persistence and function of CAR T cells in the body after CAR T cell infusion.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple Antigen-specific CAR T Cells For the Treatment of Multiple Myeloma
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

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: Single arm
CAR T cells to treat MM
 Biological: CAR T cells
Infusion of multi-CAR T cells


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with treatment related adverse effect [ Time Frame: 1 month ]
    percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.


Secondary Outcome Measures :
  1. Anti-tumor activity of fourth generation multiple CAR-T cells after infusion [ Time Frame: 1 year ]
    by measuring CAR copies in the body

  2. Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM [ Time Frame: 1 year ]
    by physical examination of tumor burden


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT).
  • Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens.
  • MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor.
  • Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year).
  • Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
  • Residual disease after primary therapy and not eligible for ASCT
  • Expected survival > 12 weeks
  • Creatinine < 2.5 mg/dl
  • ALT (alanine aminotransferase)/AST (aspartate aminotransferase) < 3x normal
  • Bilirubin < 2.0 mg/dl
  • Any relapse after prior SCT is eligible regardless of other prior therapy
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • 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.
  • Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation
  • HIV infection
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): NCT03271632


Contacts
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Contact: Lung-Ji Chang 86-075586725195 c@szgimi.org

Locations
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China, Guangdong
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195    c@szgimi.org   
China, Yunnan
The First People's Hospital of Yunnan Recruiting
Kunming, Yunnan, China, 650000
Contact: Xun Lai, Master    13577096609    1729112214@qq.com   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Investigators
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Principal Investigator: Lung-Ji Chang Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Lung-Ji Chang, Principal Investigator, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03271632    
Other Study ID Numbers: GIMI-IRB-17013
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
multiple myeloma
chimeric antigen receptor
BCMA
 CD38
CD56
CD138
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