Trial record 1 of 5 for:    Pilot Study of Redirected Autologous Tcells Engineered to Contain Anti-CD19
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CD19 Redirected Autologous T Cells for Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02277522
First received: October 27, 2014
Last updated: April 6, 2015
Last verified: April 2015
  Purpose

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 Intervention Phase
Hodgkin Lymphoma With no Available Curative Treatment Options Who Have a Limited Prognosis
Biological: RNA anti-CD19 CAR T cells
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: October 2014
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Expected survival > 12 weeks at the time of screening
  • 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 48 hours before the RNA CART19 infusion.
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Concurrent use of systemic steroids, through 72 hours post the last RNA CART19 infusion. Recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary.

    a) Therapeutic doses of steroids must be stopped >72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 6-12 mg/m2/day hydrocortisone or equivalent

  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • HIV infection.
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02277522

Contacts
Contact: Jakub Jakub Svoboda, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Jakub Svoboda, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02277522     History of Changes
Other Study ID Numbers: UPCC 04414
Study First Received: October 27, 2014
Last Updated: April 6, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 21, 2015