Clinical Trials Directory

Trials / Completed

CompletedNCT02132624

CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Uppsala University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAutologous 3rd generation CD19-targeting CAR T cellsAutologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

Timeline

Start date
2014-04-01
Primary completion
2017-05-31
Completion
2017-05-31
First posted
2014-05-07
Last updated
2017-10-30

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02132624. Inclusion in this directory is not an endorsement.