Study Summary
This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma/leukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options.
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Request More InfoInterventions
Experimental InterventionDRUG
The study intervention includes:
* Lymphapheresis
* Lymphodepleting chemotherapy
* CAR-T infusion
Lymphocytes will be collected from the patients by lymphapheresis to produce a personalized IMP, bispecific anti-CD19, anti-CD20 CAR T cells, which will be manufactured at the GMP facility of the University Hospital Basel.
Patients receive a preparative lymphodepleting chemotherapy of intravenous cyclophosphamide and fludarabine from day -5 until day -3 (or Bendamustine on day -3 and day -2), before anti-CD19/20 CAR T cells are infused (day 0 = day of infusion).
Participants will undergo lymphapheresis 2-8 weeks prior to CAR T cell infusion.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| University Hospital Basel, Division of Hematology or Medical Oncology | Basel | Canton of Basel-City | Switzerland |