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Melanoma Stage IIILONGSAFENCT06508775

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

A study testing MB-CART19.1, MB-CART20.1 and MB-CART2019.1 in people with Melanoma Stage III and B-cell Non Hodgkin Lymphoma, run by Miltenyi Biomedicine GmbH at 7 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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

Who is it for?
Any age
What is being tested?
MB-CART19.1, MB-CART20.1 and MB-CART2019.1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
7 sitesGermany
Study dates
5 May 2024to 31 Dec 2040
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • No exclusion criteria

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Manager contact

+4922048306820

clinicaltrials.gov@miltenyi.com

7 sites in 1 country

Germany7 sites, 2 recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

    Recruiting

  • Universitätsklinikum Köln

    Cologne, 50937

    Active, not recruiting

  • Uniklinikum Erlangen

    Erlangen, 91054

    Active, not recruiting

  • Universitätsmedizin Göttingen

    Göttingen, 37075

    Active, not recruiting

  • Universitätsklinikum Münster

    Münster, 48149

    Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076

    Active, not recruiting

  • Universitäts-Kinderklinik Würzburg

    Würzburg, 97080

    Active, not recruiting

Other trials in Germany

About this study

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

Read the detailed 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.

Being tested
MB-CART19.1, MB-CART20.1, MB-CART2019.1
Medical subject headings
Melanoma, Lymphoma, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MB-CART19.1Biological

    Also called CD19-targeting CAR T cells, Anti-CD19 CAR T cells

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

  • MB-CART20.1Biological

    Also called CD20-targeting CAR T cells, Anti-CD20 CAR T cells

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

  • MB-CART2019.1Biological

    Also called CD20/CD19-targeting CAR T cells, Anti-CD20/CD19 CAR T cells

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

Study groups in NCT06508775
Study groupRoleWhat they receive
Long-term follow-up of CAR T cell therapyExperimentalAssessment of long-term safety and efficacy of Miltenyi CAR T treatment.
Receives: Biological: MB-CART19.1; Biological: MB-CART20.1; Biological: MB-CART2019.1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    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

    Measured: through study completion, up to 14 years

Secondary outcomes (8)

  1. Lymphocyte count

    B and T lymphocyte count

    Measured: through study completion, up to 14 years

  2. Height

    Height

    Measured: through study completion, up to 14 years

  3. Weight

    Weight

    Measured: through study completion, up to 14 years

  4. Tanner staging for pediatric patients

    Tanner staging for pediatric patients

    Measured: through study completion, up to 14 years

  5. Menstruation status for pediatric patients

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

    Measured: through study completion, up to 14 years

  6. RCL

    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)

    Measured: through study completion, up to 14 years

  7. Relapse / Progression

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

    Measured: through study completion, up to 14 years

  8. Detectable Transgene levels

    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)

    Measured: through study completion, up to 14 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start5 May 2024
  3. Primary completion31 Dec 2040 (estimated)
  4. Study completion31 Dec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single dose treatment with CAR T cell therapy in previous trial, long-term follow-up in this trial with cohorts: MB-CART20.1 Lymphoma, MB-CART20.1 Melanoma, MB-CART19.1 pediatric ALL and progressive NHL, MB-CART19.1 adult ALL, MB-CART19.1 adult NHL/CLL, MB-CART2019.1 Lymphoma
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508775
Sponsor's protocol ID
M-2022-393
Other IDs
2022-501648-14-00
Acronym
LONGSAFE
Status last verified
Oct 2026
First submitted
11 Jun 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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