Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2028

Conditions
B Cell MalignanciesB-cell LeukemiaB Cell LymphomaBispecific Chimeric Antigen Receptor (CAR) T CellsRelapsed or Refractory (r/r) B-cell Malignancies
Interventions
DRUG

Experimental Intervention

"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."

Trial Locations (1)

4031

University Hospital Basel, Division of Hematology or Medical Oncology, Basel

All Listed Sponsors
lead

University Hospital, Basel, Switzerland

OTHER