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CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.

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: NCT02132624
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Uppsala University Hospital
Karolinska University Hospital
AFA Insurance
Swedish Cancer Society
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma B Cell Leukemia Biological: Autologous 3rd generation CD19-targeting CAR T cells Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
Study Start Date : April 2014
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017


Arm Intervention/treatment
Experimental: CAR T cells
Autologous 3rd generation CD19-targeting CAR T cells
Biological: Autologous 3rd generation CD19-targeting CAR T cells
Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.




Primary Outcome Measures :
  1. CAR T cell persistence [ Time Frame: At week 1 and 5, there after every 3 months post treatment up to 24 months ]
    Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood.


Secondary Outcome Measures :
  1. Tumor load [ Time Frame: Every 3 months post treatment up to 24 months ]
    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.


Other Outcome Measures:
  1. B cell number and immunoglobulins [ Time Frame: Weekly for 5 weeks, then every 3 months post treatment up to 24 months ]
    Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed or refractory CD19+ B-cell lymphoma or leukemia.
  • Measurable disease.
  • Performance status ECOG 0-2.
  • >18 years old.
  • Fertile females/males must consent to use contraceptives during participation of the trial.
  • Signed informed consent.

Exclusion Criteria:

  • Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
  • Patients with primary CNS lymphoma.
  • Known human immunodeficiency virus (HIV) infection.
  • Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
  • Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
  • Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
  • Patients that do not consent to that tissue and blood samples are stored in a biobank.
  • Pregnancy

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): NCT02132624


Locations
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Sweden
Uppsala University Hospital, Dept of Oncology
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Uppsala University Hospital
Karolinska University Hospital
AFA Insurance
Swedish Cancer Society
Investigators
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Study Director: Angelica Loskog, PhD Uppsala University
Principal Investigator: Gunilla Enblad, MD, PhD Uppsala University Hospital
Principal Investigator: Hans Hagberg, MD, PhD Uppsala University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02132624    
Other Study ID Numbers: 003:TCELL
2013-001393-19 ( EudraCT Number )
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia