A Phase I Trial of Bispecific Anti-CD19, Anti-CD20 CAR T Cells for B Cell Malignancies (BaseCAR-01)

NCT07166549 Phase 1 NOT_YET_RECRUITING

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.

Details

Lead sponsor	University Hospital, Basel, Switzerland
Phase	Phase 1
Status	NOT_YET_RECRUITING
Enrolment	12
Start date	2026-06
Completion	2028-11

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

• Experimental Intervention

Primary outcomes

• Evaluation of Adverse Events — up to 3 months after CAR T cell infusion
  All adverse events will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the CTCAE Version v5.0.
• Evaluation of Adverse Events of special interest (CRS) — up to 3 months after CAR T cell infusion
  All adverse events of special interest (CRS) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the ASTCT CRS Consensus Grading (Grade 1 up to Grade 4; with Grade 4 as most severe CRS Grade)
• Evaluation of Adverse Events of special interest (ICANS) — up to 3 months after CAR T cell infusion
  All adverse events of special interest (ICANS) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the Immune-effector Cell-associated Encephalopathy (ICE) test, which was developed to provide objectivity for screening and grading the severity of ICANS. The ICE score is performed at least every 8 hours during in-patient care and at every outpatient visit. A higher score indicates better cognitive function, with a perfect score of 10 signifying no impairment.
• Evaluation of Adverse Events of special interest (ICAHT) — up to 3 months after CAR T cell infusion
  Evaluation of Adverse Events of special interest (ICAHT) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the EHA/EBMT consensus grading. The EHA/EBMT consensus grading score is a classification system based on depth and duration of neutropenia.

Countries

Switzerland