drugset / Trial / NCT03853616

MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)

NCT03853616

Phase 1 Active not recruiting 48 enrolled Miltenyi Biomedicine GmbH
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase l multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. In total approximately 48 patients will be included in the trial. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).

Timeline

Start
2018-11-26
Primary completion
2026-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-CD19 CAR-T cells Cell therapy 100000 cells
Subject anti-CD19 CAR-T cells Cell therapy 500000 cells
Subject anti-CD19 CAR-T cells Cell therapy 1e+06 cells
Subject anti-CD19 CAR-T cells Cell therapy 3e+06 cells