NCT02374333

Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy

Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 Attached to TCRζ and 4-1BB Signaling Domains in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 1 Year – 24 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to evaluate humanized CD19 redirected autologous T cells (or huCART19 cells) in patients with relapsed or refractory CD19+ leukemia and lymphoma that was previously treated with cell therapy. This study is targeting pediatric patients aged 1-24 years with CD19+ B cell malignancies with no available curative treatment options (such as autologous or allogeneic stem cell transplantation) who have a limited prognosis with currently available therapies and were previously treated with a B cell directed engineered cell therapy product.

Conditions

• Acute Lymphocytic Leukemia
• Diffuse Large Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	huCART19

Timeline

• Start date: 2014-03-25
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2015-02-27
• Last updated: 2021-09-23

Locations

1 site across 1 country: United States