OncRef

Clinical Trial: NCT03853616

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Miltenyi Biomedicine GmbH
Information Provided By:Miltenyi Biomedicine GmbH
Last Update Posted:2026-10-09

Study Overview

Brief 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).

Official Title

A Phase I Safety, Dose Finding and Feasibility Trial of MB-CART19.1 in Patients With Relapsed or Refractory CD19 Positive B Cell Malignancies

Conditions

Acute Lymphoblastic Leukemia Recurrent, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory, Chronic Lymphocytic Leukemia Recurrent, Chronic Lymphocytic Leukemia Refractory

Intervention / Treatment

  • Biological: MB-CART19.1

Other Study ID Numbers

  • M-2017-322
  • 2017-002848-32
  • 2017

Start Date (Actual)

2018-11-26

Primary Completion Date (Estimated)

2026-11

Study Completion Date (Estimated)

2026-11

Enrollment (Estimated)

48

Study Type

Interventional

Phase

Phase 1