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

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06508775
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Miltenyi Biomedicine GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Claudia Rössig, Prof. Dr.
Principal Investigator Affiliation	Universitätsklinikum Münster
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma Stage III, B-cell Non Hodgkin Lymphoma, Pediatric ALL, Childhood Non-Hodgkin Lymphoma, Acute Lymphatic Leukemia, Chronic Lymphatic Leukemia, Melanoma Stage IV

Additional Details

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.

Arms & Interventions

Arms

Experimental: Long-term follow-up of CAR T cell therapy

Assessment of long-term safety and efficacy of Miltenyi CAR T treatment.

Interventions

Biological: - MB-CART19.1

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

Biological: - MB-CART20.1

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

Biological: - MB-CART2019.1

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.