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CD19 Redirected Autologous T Cells for Hodgkin Lymphoma

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. Identifier: NCT02277522
Recruitment Status : Terminated (unable to meet enrollment goal)
First Posted : October 29, 2014
Last Update Posted : November 9, 2017
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as RNA CART19) in Hodgkin Lymphoma (HL) patients.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma With no Available Curative Treatment Options Who Have a Limited Prognosis Biological: RNA anti-CD19 CAR T cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Linked to TCRζ and 4-1BB Signaling Domains in Patients With Chemotherapy Relapsed or Refractory Hodgkin Lymphoma
Study Start Date : October 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : June 27, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RNA autologous T cells (anti CD19 CAR T cells) Biological: RNA anti-CD19 CAR T cells
intravenously administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as RNA CART19)

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female subjects with HL with no available curative treatment options (such as autologous SCT) who have a limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.

    i. HL with biopsy-proven relapse or refractory disease who are unresponsive to or intolerant of at least one line of standard salvage therapy ii. Patients must have evaluable disease by radiologic imaging (FDG PET/CT or PET/MRI) within 42 days of enrollment; evaluable includes both assessable and/or measurable disease as defined by Cheson et al., 2007.

  • Age ≥ 18 years of age
  • Creatinine < 1.6 mg/dl.
  • ALT/AST < 3x upper limit of normal
  • Bilirubin < 2.0 mg/dl, unless subject has Gilbert's syndrome (≤3.0 mg/dL)
  • Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and

    1. Have no active GVHD and require no immunosuppression
    2. Are more than 6 months from transplant
  • Performance status (ECOG) 0 or 1.
  • Left Ventricular Ejection Fraction (LVEF) ≥ 40% as confirmed by ECHO/MUGA
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
  • Written informed consent is given.
  • Successful T cell test expansion (to be performed as part of inclusion criteria until 3 subjects meet all enrollment criteria)

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 pregnancy test at enrollment. A urine or serum pregnancy test will be performed within 72 hours before the first RNA CART19 infusion.
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • HIV infection.
  • Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
  • Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment
  • Patients in complete remission with no evidence of evaluable disease by radiologic imaging.
  • History of allergy to murine proteins.
  • History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
  • Anti-CD20 monoclonal antibody therapy within the last 3 months, or absence of circulating B cells.
  • Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).

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 identifier (NCT number): NCT02277522

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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Jakub Svoboda, MD Abramson Cancer Center of the University of Pennsylvania
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Pennsylvania Identifier: NCT02277522    
Other Study ID Numbers: UPCC 04414, 820840
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases