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

NCT03853616 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-16

No results posted yet for this study

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).

Conditions

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

Interventions

BIOLOGICAL

MB-CART19.1

MB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD19-positive tumor cells in b cell malignancies

Sponsors & Collaborators

  • Miltenyi Biomedicine GmbH

    lead INDUSTRY

Principal Investigators

  • Claudia Rössig, Prof. Dr. · Univeristy Hospital Muenster

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853616 on ClinicalTrials.gov