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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

Tracking Information
First Submitted Date  ICMJE May 5, 2014
First Posted Date  ICMJE May 7, 2014
Last Update Posted Date October 30, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 5, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
Official Title  ICMJE CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
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.
Detailed Description Not Provided
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
  • B Cell Lymphoma
  • B Cell Leukemia
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: CAR T cells
Autologous 3rd generation CD19-targeting CAR T cells
Intervention: Biological: Autologous 3rd generation CD19-targeting CAR T cells
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2014)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2017
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02132624
Other Study ID Numbers  ICMJE 003:TCELL
2013-001393-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE
  • Uppsala University Hospital
  • Karolinska University Hospital
  • AFA Insurance
  • Swedish Cancer Society
Investigators  ICMJE
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
PRS Account Uppsala University
Verification Date October 2017

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