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.
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
- Conditions the study is for
- Melanoma Stage III, B-cell Non Hodgkin Lymphoma, Pediatric ALL
- 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
- Are there results?
- Not yet: the study is under way
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.
7 sites in 1 country
Germany7 sites, 2 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
- Active, not recruiting
Universitätsklinikum Köln
Cologne, 50937
- Active, not recruiting
Uniklinikum Erlangen
Erlangen, 91054
- Active, not recruiting
Universitätsmedizin Göttingen
Göttingen, 37075
- Recruiting
Universitätsklinikum Münster
Münster, 48149
- Active, not recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
- Active, not recruiting
Universitäts-Kinderklinik Würzburg
Würzburg, 97080
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.
- Conditions
- Melanoma Stage III, B-cell Non Hodgkin Lymphoma, Pediatric ALL, Childhood Non-Hodgkin Lymphoma, Acute Lymphatic Leukemia, Chronic Lymphatic Leukemia
- 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 group | Role | What they receive |
|---|---|---|
| Long-term follow-up of CAR T cell therapy | Experimental | Assessment 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.
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)
Lymphocyte count
B and T lymphocyte count
Measured: through study completion, up to 14 years
Height
Height
Measured: through study completion, up to 14 years
Weight
Weight
Measured: through study completion, up to 14 years
Tanner staging for pediatric patients
Tanner staging for pediatric patients
Measured: through study completion, up to 14 years
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
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
Relapse / Progression
Percentage of patients who relapse or progress since enrollment and rate of surviving patients
Measured: through study completion, up to 14 years
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.
- First posted18 Jul 2024
- Study start5 May 2024
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma Stage IIIStudies of the same condition, open and under way.
- More trials run by Miltenyi Biomedicine GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Rössig, Prof. Dr., Principal investigator, Universitätsklinikum Münster
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
- ClinicalTrials.gov ID
- NCT06508775
- Acronym / sponsor ID
- LONGSAFE / M-2022-393
- Conditions
- Melanoma Stage III, B-cell Non Hodgkin Lymphoma, Pediatric ALL, Childhood Non-Hodgkin Lymphoma, Acute Lymphatic Leukemia, Chronic Lymphatic Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 May 2024 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Long-term follow-up of CAR T cell therapy | Experimental | Biological: MB-CART19.1, Biological: MB-CART20.1, Biological: MB-CART2019.1Assessment of long-term safety and efficacy of Miltenyi CAR T treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-CART19.1Also: CD19-targeting CAR T cells, Anti-CD19 CAR T cellsAssessment of long-term safety and efficacy of MB-CART19.1 treatment. | Biological | Long-term follow-up of CAR T cell therapy |
| MB-CART20.1Also: CD20-targeting CAR T cells, Anti-CD20 CAR T cellsAssessment of long-term safety and efficacy of MB-CART20.1 treatment. | Biological | Long-term follow-up of CAR T cell therapy |
| MB-CART2019.1Also: CD20/CD19-targeting CAR T cells, Anti-CD20/CD19 CAR T cellsAssessment of long-term safety and efficacy of MB-CART2019.1 treatment. | Biological | Long-term follow-up of CAR T cell therapy |
Primary outcome
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
8 secondary outcomes
Lymphocyte count
Time frame: through study completion, up to 14 years
Height
Time frame: through study completion, up to 14 years
Weight
Time frame: through study completion, up to 14 years
Tanner staging for pediatric patients
Time frame: through study completion, up to 14 years
Menstruation status for pediatric patients
Time frame: through study completion, up to 14 years
RCL
Time frame: through study completion, up to 14 years
Relapse / Progression
Time frame: through study completion, up to 14 years
Detectable Transgene levels
Time frame: through study completion, up to 14 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Rössig, Prof. Dr. principal investigator
Universitätsklinikum Münster
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager (+4922048306820, clinicaltrials.gov@miltenyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: through study completion, up to 14 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.