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Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients

NCT04844866 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2026-04-29

No results posted yet for this study

Summary

In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

Part II is a Phase II single-arm, open-label, multi-centre study evaluating the efficacy and safety of MB-CART2019.1 in younger, fit participants with R-R DLBCL. Part II will start after completion of enrolment in Part I.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

GENETIC

MB-CART2019.1

MB-CART2019.1 is designed to effectively target malignant B cells in patients suffering from late stage haematological B-cell malignancies. MB-CART2019.1 consists of autologous cluster of differentiation CD20/CD19 chimeric antigen receptor (CAR) transduced CD4/CD8 enriched T cells, derived from a leukapheresis and processed by using the CliniMACS Prodigy® device.

DRUG

Standard of Care

Standard of Care

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Miltenyi Biomedicine GmbH

    lead INDUSTRY

Principal Investigators

  • Peter Borchmann, Prof. Dr. · University Hospital Cologne

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2025-01-15
Completion
2031-09-30

Countries

  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

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 NCT04844866 on ClinicalTrials.gov