NCT06508775

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Miltenyi Biomedicine GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma Stage III
• B-cell Non Hodgkin Lymphoma
• Pediatric ALL
• Childhood Non-Hodgkin Lymphoma
• Acute Lymphatic Leukemia
• Chronic Lymphatic Leukemia
• Melanoma Stage IV

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-05
• Primary completion: 2040-12-31
• Completion: 2040-12-31
• First posted: 2024-07-18
• Last updated: 2025-11-26

Locations

7 sites across 1 country: Germany