Study Summary
This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.
Want to learn more about this trial?
Request More InfoInterventions
CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg)BIOLOGICAL
The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design.
Dose Level -1: 5 x 10\^5 CAR-20/19-T cells/kg
CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg)BIOLOGICAL
The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design.
Dose Level 0: 1 x10\^6 CAR-20/19-T cells/kg (starting dose level)
CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)BIOLOGICAL
The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design.
Dose Level 1: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)
CAR-20/19-T cellsBIOLOGICAL
The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design.
The dose expansion dose level is still to be determined and this section will be updated.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | United States |