RecruitingRecruiting
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
NCT06508775 · Miltenyi Biomedicine GmbH
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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.
Eligibility 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
Study design
Enrollment target: 40 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2024-05-05
Estimated completion: 2040-12-31
Last updated: 2025-11-26
Interventions
Biological: MB-CART19.1Biological: MB-CART20.1Biological: MB-CART2019.1
Primary outcomes
- • Adverse Events (through study completion, up to 14 years)
Sponsor
Miltenyi Biomedicine GmbH · industry
Contacts & investigators
ContactClinical Trial Manager · contact · clinicaltrials.gov@miltenyi.com · +4922048306820
InvestigatorClaudia Rössig, Prof. Dr. · principal_investigator, Universitätsklinikum Münster
All locations (7)
Charité Universitätsmedizin BerlinRecruiting
Berlin, Germany
Universitätsklinikum KölnActive Not Recruiting
Cologne, Germany
Uniklinikum ErlangenActive Not Recruiting
Erlangen, Germany
Universitätsmedizin GöttingenActive Not Recruiting
Göttingen, Germany
Universitätsklinikum MünsterRecruiting
Münster, Germany
Universitätsklinikum TübingenActive Not Recruiting
Tübingen, Germany
Universitäts-Kinderklinik WürzburgActive Not Recruiting
Würzburg, Germany