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Treatment of Chemotherapy Refractory Multiple Myeloma by CART-138 (CART-138)

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: NCT01886976
Recruitment Status : Unknown
Verified January 2016 by Han weidong, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2013
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Study Description
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Brief Summary:

RATIONALE: 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.

PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with CD138 positive multiple myeloma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.


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

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD138 vector (referred to as CART-138 cells).

II. Determine duration of in vivo survival of CART-138 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood and bone marrow will be used to detect and quantify survival of CART-138 TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.

SECONDARY OBJECTIVES:

I. For patients with detectable disease, measure anti-myeloma response due to CART-138 cell infusions.

II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-138 TCR zeta:CD137 and TCR zeta cells over time.

III. Estimate relative trafficking of CART-138 cells in bone marrow.

IV. For patients with stored or accessible myeloma cells, determine myeloma cell killing by CART-138 cells in vitro.

V. Determine if cellular or humoral host immunity develops against the murine anti-CD138, and assess correlation with loss of detectable CART-138 (loss of engraftment).

VI. Determine the relative subsets of CART-138 T cells (Tcm, Tem, and Treg).

OUTLINE: Patients are assigned to 1 group according to order of enrollment.

Patients receive anti-CD138-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.

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: Clinical Study of Chimeric CD(Cluster of Differentiation)138 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Multiple Myelomas
Study Start Date : June 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

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: anti-CD138 CAR T cells
Patients receive anti-CD138-CAR retroviral vector-transduced autologous or donor-derived T cells on days 0,1, 2 in the absence of disease progression or unacceptable toxicity.
 Biological: CART-138 cells
Other Name: chimeric antigen receptor T cells with specificity for CD138 genetically modified lymphocyte therapy


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: Until week 24 ]
    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment


Secondary Outcome Measures :
  1. Anti-myeloma responses to CART-138 cell infusions [ Time Frame: up to 24 weeks ]
    by measuring the changes of aberrant immunoglobulin in serum and multiple myeloma cells in bone marrow.


Other Outcome Measures:
  1. in vivo existence of CART-138 [ Time Frame: 1 year ]
    measurement of CART-138 cells in peripheral blood by 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 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects with CD138 positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
  • CD138 positive multiple myeloma CR can not be achieved after at least 4 prior combination chemotherapy regimens.
  • MM in CR(complete remission)2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated 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 autologous SCT

    • 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 will make patient 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
  • The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
  • 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
  • Feasibility assessment during screening demonstrates < 30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD137 costimulation.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • 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): NCT01886976


Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, Ph.D    86-10-13651392893    hanwdrsw@sina.com   
Contact: Bo Guo, Ph.D    86-10-15201186743    drguobo@163.com   
Principal Investigator: Yao Wang, Ph.D         
Principal Investigator: Quanshun Wang, Ph.D         
Sponsors and Collaborators
Chinese PLA General Hospital
More Information
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Responsible Party: Han weidong, principal investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01886976    
Other Study ID Numbers: CHN-PLAGH-BT-008
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by Han weidong, Chinese PLA General Hospital:
multiple myeloma
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