Pilot Study of Non-Viral, RNA-Redirected Autologous T Cells in Patients With Refractory or Relapsed Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02624258|
Recruitment Status : Terminated (Principal Investigator decision to stop trial)
First Posted : December 8, 2015
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Biological: CD19 RNA redirected autologous T-cells (RNA CART19 cells)||Early Phase 1|
The study will enroll 10 evaluable patients. Evaluable patients are those who have received at least 1 of the 6 RNA CART19 doses at the protocol-specified level. Important safety data can be collected even if a patient receives only one RNA CART19 dose. Subjects (n = 10) will receive up to six IV doses of 8x105-1.5x106 RNA CART19 cells/kg/dose for subjects<80kg and 1x108 RNA CART19 cells/dose (±20%) for subjects ≥80kg.
The RNA CART19 doses and mid-treatment single dose cyclophosphamide will be administered on Mondays, Wednesdays or Fridays. Dosing can be initiated on any of those days. Subjects will be infused in a staggered fashion at two week intervals; that is, the next subject cannot be infused prior to two weeks since the last infusion of the previous subject.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Non-Viral, RNA-Redirected Autologous T Cells Engineered to Contain Anti-CD19 Linked to TCR and 4-1BB Signaling Domains in Patients With Refractory or Relapsed Hodgkin Lymphoma|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||June 5, 2019|
|Actual Study Completion Date :||December 6, 2019|
Experimental: RNA CART19 cells
CD19 RNA redirected autologous T-cells (RNA CART19 cells)
Biological: CD19 RNA redirected autologous T-cells (RNA CART19 cells)
Subjects will be treated with IV administration of RNA anti-CD19 CAR T cells for a total of six doses over 3 weeks. The first dose will be administered 1-4 days after infusion of cyclophosphamide 30mg/kg.
- Incidence of Treatment-Emergent Adverse Events, defined as NCI CTCAE V4 > Grade 3 [ Time Frame: Month 4 post-CART19 Infusion ]Occurrence of study related adverse events, defined as NCI CTCAE V4 > grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible, likely or definitely related to study treatment at any time from the first cyclophosphamide infusion until Month 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624258
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Susan Rheingold, MD||Children's Hospital of Philadelphia|