NCT07166549

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

A Phase I Trial of Bispecific Anti-CD19, Anti-CD20 CAR T Cells for B Cell Malignancies

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chimeric antigen receptor (CAR) T cells are engineered T-lymphocytes with artificial receptors, containing domains of a T cell receptor as well as a B cell receptor with predefined specificity to a target antigen. In patients with relapsed or refractory (r/r) B-cell malignancies, who would otherwise have a poor prognosis, CD19-directed CAR T cell therapy showed high response rates. A common cause of relapse is loss of the target antigen on the tumor cells, e.g. CD19. In such cases, further approved treatment options are very limited to date, but recent preclinical and early clinical studies have shown that bispecific anti-CD19, anti-CD20 CAR T cells can overcome this hurdle, adding a second target and leading to excellent outcomes in heavily pretreated patients. 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. A secondary objective is the assessment of efficacy.

Conditions

• B Cell Malignancies
• B-cell Leukemia
• B Cell Lymphoma
• Bispecific Chimeric Antigen Receptor (CAR) T Cells
• Relapsed or Refractory (r/r) B-cell Malignancies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-09-10
• Last updated: 2025-12-24

Locations

1 site across 1 country: Switzerland