Long-term follow-up for patients treated with Miltenyi CAR T therapies
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
This study looks at how well Miltenyi CAR T cell therapies work and their long-term safety for patients, especially kids, who have already been treated.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Miltenyi Biomedicine GmbH Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 7 sites (Berlin and 6 other locations) |
| Trial ID | NCT06508775 on ClinicalTrials.gov |
What this trial studies
This trial focuses on the long-term safety and efficacy of Miltenyi CAR T cell therapies in patients who have previously undergone treatment. It aims to monitor late adverse reactions, serious adverse events, and disease progression over time. The study will track various health outcomes, including the detection of CAR T cell transgenes and any new malignancies, particularly in pediatric patients. Overall survival and disease status will also be assessed to understand the long-term impact of the therapies.
Who should consider this trial
Good fit: Ideal candidates are patients who have received Miltenyi CAR T cell therapy at least 12 months prior to enrollment.
Not a fit: Patients who have not undergone Miltenyi CAR T cell therapy or those who are not able to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of CAR T therapies for patients with certain types of cancer.
How similar studies have performed: Other studies on CAR T therapies have shown promising results, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full 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
Where this trial is running
Berlin and 6 other locations
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Universitätsklinikum Köln — Cologne, Germany (Active_not_recruiting)
- Uniklinikum Erlangen — Erlangen, Germany (Active_not_recruiting)
- Universitätsmedizin Göttingen — Göttingen, Germany (Active_not_recruiting)
- Universitätsklinikum Münster — Münster, Germany (Recruiting)
- Universitätsklinikum Tübingen — Tübingen, Germany (Active_not_recruiting)
- Universitäts-Kinderklinik Würzburg — Würzburg, Germany (Active_not_recruiting)
Study contacts
- Principal investigator: Claudia Rössig, Prof. Dr. — Universitätsklinikum Münster
- Study coordinator: Clinical Trial Manager
- Email: clinicaltrials.gov@miltenyi.com
- Phone: +4922048306820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.