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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

Tracking Information
First Submitted Date  ICMJE August 27, 2017
First Posted Date  ICMJE September 5, 2017
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE July 15, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
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 labs and so on.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • Anti-tumor activity of fourth generation multiple CAR-T cells after infusion [ Time Frame: 1 year ]
    by measuring CAR copies in the body
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory MM [ Time Frame: 1 year ]
scale of CAR copies and tumor burden
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma
Official Title  ICMJE Multiple Antigen-specific CAR T Cells For the Treatment of Multiple Myeloma
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Biological: CAR T cells
Infusion of multi-CAR T cells
Study Arms  ICMJE Experimental: Single arm
CAR T cells to treat MM
Intervention: Biological: CAR T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2017)
20
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2017)
10
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03271632
Other Study ID Numbers  ICMJE GIMI-IRB-17013
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shenzhen Geno-Immune Medical Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lung-Ji Chang Shenzhen Geno-Immune Medical Institute
PRS Account Shenzhen Geno-Immune Medical Institute
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP