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

University of Pennsylvania1 site in 1 country4 target enrollmentOctober 2014

ConditionsHodgkin Lymphoma With no Available Curative Treatment Options Who Have a Limited Prognosis

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Hodgkin Lymphoma With no Available Curative Treatment Options Who Have a Limited Prognosis
Sponsor: University of Pennsylvania
Enrollment: 4
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

June 27, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

Eligibility 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.,
•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
•Have no active GVHD and require no immunosuppression
•Are more than 6 months from transplant
•Performance status (ECOG) 0 or

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).