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NCT Number: NCT06508775

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

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

Recruiting

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Key information

Conditions

Melanoma Stage III Acute Lymphatic Leukemia B-cell Non Hodgkin Lymphoma Childhood Non-Hodgkin Lymphoma Chronic Disease Chronic Lymphatic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Melanoma Melanoma Stage IV Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Universitätsmedizin Berlin, Berlin, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

MB-CART19.1

Biological

Assessment of long-term safety and efficacy of MB-CART19.1 treatment.

Other names: CD19-targeting CAR T cells, Anti-CD19 CAR T cells

MB-CART20.1

Biological

Assessment of long-term safety and efficacy of MB-CART20.1 treatment.

Other names: CD20-targeting CAR T cells, Anti-CD20 CAR T cells

MB-CART2019.1

Biological

Assessment of long-term safety and efficacy of MB-CART2019.1 treatment.

Other names: CD20/CD19-targeting CAR T cells, Anti-CD20/CD19 CAR T cells

Primary outcomes

  1. Adverse Events

    Time frame: through study completion, up to 14 years

    Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies

Secondary outcomes

  1. Lymphocyte count

    Time frame: through study completion, up to 14 years

    B and T lymphocyte count

  2. Height

    Time frame: through study completion, up to 14 years

    Height

  3. Weight

    Time frame: through study completion, up to 14 years

    Weight

  4. Tanner staging for pediatric patients

    Time frame: through study completion, up to 14 years

    Tanner staging for pediatric patients

  5. Menstruation status for pediatric patients

    Time frame: through study completion, up to 14 years

    Did the patient experience their first menstrual cycle (menarche)? If yes, enter date

  6. RCL

    Time frame: through study completion, up to 14 years

    Percentage of patients with detectable replication-competent lentivirus (RCL) (if results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient; if results of all samples in first year of primary trial were negative for an individual patient, sampling will not be continued for this patient in this long-term follow-up trial)

  7. Relapse / Progression

    Time frame: through study completion, up to 14 years

    Percentage of patients who relapse or progress since enrollment and rate of surviving patients

  8. Detectable Transgene levels

    Time frame: through study completion, up to 14 years

    Percentage of patients with detectable transgene levels (if results of 2 consecutive years are negative for an individual patient, further sampling will be stopped for this patient)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Manager

CONTACT

[email protected]

+4922048306820

Sponsors and collaborators

Lead sponsor

Miltenyi Biomedicine GmbH

Industry

Registry information

Acronym: LONGSAFE

Important dates

Study start
2024
Primary completion
2040
Study completion
2040
First posted
Jul 18, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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