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

Phase 0 Terminated 2 enrolled University of Pennsylvania Children's Hospital of Philadelphia · collab

NaSingle-groupOpen-labelTreatment

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 TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains (referred to as "RNA CART19") in Hodgkin Lymphoma (HL) patients. Subjects will be treated with IV administration of RNA anti-CD19 CAR T cells for a total of six doses over 3 weeks.

Timeline

Start: 2015-11
Primary completion: 2019-06-05
Completion: 2019-12-06

Outcome

Outcome not reported

Stopped: “Principal Investigator decision to stop trial”

Publications

Svoboda J, Rheingold SR, Gill SI, Grupp SA, Lacey SF, Kulikovskaya I, Suhoski MM, Melenhorst JJ, Loudon B, Mato AR, Nasta SD, Landsburg DJ, Youngman MR, Levine BL, Porter DL, June CH, Schuster SJ. Nonviral RNA chimeric antigen receptor-modified T cells in patients with Hodgkin lymphoma. Blood. 2018 Sep 6;132(10):1022-1026. doi: 10.1182/blood-2018-03-837609. Epub 2018 Jun 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RNA CART19 cells	Cell therapy	800000 cells/kg	Intravenous
Subject	RNA CART19 cells	Cell therapy	1.5e+06 cells/kg	Intravenous
Subject	RNA CART19 cells	Cell therapy	1e+08 cells	Intravenous