Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies

Last updated: July 19, 2024
Sponsor: Miltenyi Biomedicine GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Leukemia

Melanoma

Treatment

MB-CART19.1

MB-CART20.1

MB-CART2019.1

Clinical Study ID

NCT06508775
M-2022-393
2022-501648-14-00
  • All Genders

Study Summary

The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parenttrials at least 12 months prior to enrollment in long-term follow-up.

  • Patient has provided informed consent prior to enrollment.

Exclusion

Exclusion Criteria:

  • No exclusion criteria

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: MB-CART19.1
Phase:
Study Start date:
May 05, 2024
Estimated Completion Date:
December 31, 2040

Study Description

The focus in this trial is on the occurrence of any late adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI), i.e. relapse or progression of the underlying disease, life-threatening infections, death due to any case, new and secondary malignancies, lymphocyte counts, detection of the transgene of the CAR T cells, detection of replication-competent lentivirus (RCL), developmental tracking in pediatric patients and furthermore, assessment of the primary status of disease progression and overall survival.

Connect with a study center

  • Universitätsklinikum Köln

    Cologne, 50937
    Germany

    Active - Recruiting

  • Universitätsmedizin Göttingen

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Active - Recruiting

  • Universitäts-Kinderklinik Würzburg

    Würzburg, 97080
    Germany

    Active - Recruiting

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