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

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.

Trial Details

NCT ID
NCT04844866
Phase
PHASE2
Sponsor
Miltenyi Biomedicine GmbH
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • MB-CART2019.1
  • Standard of Care
Locations (sample)
  • Graz, Austria|47.06733,15.44197
  • Innsbruck, Austria|47.26266,11.39454
  • Linz, Austria|48.30639,14.28611
  • Vienna, Austria|48.20849,16.37208
  • Anderlecht, Belgium|50.83619,4.31454

Key Eligibility Criteria

  • Histologically proven DLBCL and associated subtypes, according to the World Health Organization (WHO) 2016 classification including:
  • DLBCL not otherwise specified (NOS).
  • High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements with DLBCL/blastoid/intermediate histology or HGBL with MYC and BCL2…
  • High-grade BCL, NOS.

For full eligibility, visit ClinicalTrials.gov.

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