Pilot Study of Non-Viral, RNA-Redirected Autologous T Cells in Patients With Refractory or Relapsed Hodgkin Lymphoma

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.

- HL with biopsy-proven relapse or refractory disease who are unresponsive to or
intolerant of at least one line of standard salvage therapy;

- Patients must have evaluable disease by radiologic imaging (FDG PET-CT or FDG
PET-MRI) within 42 day of enrollment; evaluable includes both assessable and/or
measurable disease

- Age 18 to 24 years. Patients ages 22-24 will only be enrolled if they are currently
being treated at CHOP or another pediatric facility/oncologist.

- Expected survival > 12 weeks at time of screening

- Adequate organ function defined as:

- Renal function defined as:

- Creatinine clearance or radioisotope GFR > 60 mL/min/1.73 m2 OR

- Serum creatinine: < 1.7mg/dL (male subjects) or < 1.4mg/dL (female subjects)

- ALT < 5 times the ULN for age

- Total Bilirubin < 2.0 mg/dl

- Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse
oxygenation > 94% on room air

- Patients with relapsed disease after prior allogeneic SCT (myeloablative or
non-myeloablative) will be eligible if they meet all other inclusion criteria and

- Have no active GVHD and require no immunosuppression

- Are more than 6 months from transplant 6) Karnofsky performance status ≥ 50 at
screening

- Left Ventricular Shortening Fraction (LVSF) > 28% confirmed by echocardiogram, or Left
Ventricular Ejection Fraction (LVEF) > 45% confirmed by echocardiogram or MUGA

- Signed written informed consent must be obtained prior to any study procedures

- 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 pregnancy test will be performed within 48 hours
before the 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 known 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 by radiologic imaging of disease.

- 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

- Unstable angina and/or myocardial infarction within 6 months prior to screening.