CD19 Redirected Autologous T Cells for Hodgkin Lymphoma



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/11/2017
Start Date:October 2014
End Date:June 27, 2017

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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

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.


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).
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Jakub Svoboda, MD
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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from
Philadelphia, PA
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