Actively Recruiting
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Led by Miltenyi Biomedicine GmbH · Updated on 2025-11-26
40
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the long-term safety and effectiveness of Miltenyi CAR T cell therapies in patients treated for various blood cancers and melanoma stages III and IV, including pediatric acute lymphatic leukemia. It focuses on monitoring late adverse reactions, serious side effects, disease relapse or progression, infections, and survival over an extended period. The study also tracks developmental progress in pediatric participants and examines important biological markers related to the therapy. Participants will be followed after receiving one of several Miltenyi CAR T cell treatments: MB-CART19.1, MB-CART20.1, or MB-CART2019.1. The trial evaluates these biological therapies over a long-term period, up to 14 years, without additional treatment interventions. The primary goal is to observe any adverse events related to the therapies throughout this extended timeframe. During the study, participants will undergo regular assessments including lymphocyte counts, height and weight measurements, Tanner staging and menstruation status for pediatric patients, detection of therapy-related genetic material, and monitoring for disease relapse or progression. The study continuously tracks adverse events to ensure thorough safety monitoring. Participants remain engaged in follow-up visits and evaluations for up to 14 years to provide comprehensive long-term data.
CONDITIONS
Brief Title
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 years
Participants are followed to assess long-term safety and efficacy after Miltenyi CAR T cell therapy. This includes monitoring for adverse reactions, disease progression, survival, and developmental tracking in pediatric patients.
Periodic visits as scheduled throughout the study duration
Trial Site Locations
Total: 7 locations
1
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
2
Universitätsklinikum Köln
Cologne, Germany, 50937
Active, Not Recruiting
3
Uniklinikum Erlangen
Erlangen, Germany, 91054
Active, Not Recruiting
4
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Active, Not Recruiting
5
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
6
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Active, Not Recruiting
7
Universitäts-Kinderklinik Würzburg
Würzburg, Germany, 97080
Active, Not Recruiting
Research Team
C
Clinical Trial Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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