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

NCT06508775 | Recruiting

• 2 other identifiers: M-2022-3932022-501648-14-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies

  through study completion, up to 14 years

Secondary Outcomes (8)

• Lymphocyte count

  through study completion, up to 14 years

• Height

  through study completion, up to 14 years

• Weight

  through study completion, up to 14 years

• Tanner staging for pediatric patients

  through study completion, up to 14 years

• Menstruation status for pediatric patients

  through study completion, up to 14 years

Study Arms (1)

Long-term follow-up of CAR T cell therapy

EXPERIMENTAL

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

Biological: MB-CART19.1; Biological: MB-CART20.1; Biological: MB-CART2019.1

Interventions

MB-CART19.1 BIOLOGICAL

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

Also known as: CD19-targeting CAR T cells, Anti-CD19 CAR T cells

Long-term follow-up of CAR T cell therapy

MB-CART20.1 BIOLOGICAL

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

Also known as: CD20-targeting CAR T cells, Anti-CD20 CAR T cells

Long-term follow-up of CAR T cell therapy

MB-CART2019.1 BIOLOGICAL

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

Also known as: CD20/CD19-targeting CAR T cells, Anti-CD20/CD19 CAR T cells

Long-term follow-up of CAR T cell therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Miltenyi Biomedicine GmbH: lead

Study Sites (7)

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Universitätsklinikum Köln

Cologne, 50937, Germany

ACTIVE NOT RECRUITING

Uniklinikum Erlangen

Erlangen, 91054, Germany

ACTIVE NOT RECRUITING

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Münster

Münster, 48149, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

ACTIVE NOT RECRUITING

Universitäts-Kinderklinik Würzburg

Würzburg, 97080, Germany

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Melanoma; Lymphoma, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Rössig, Prof. Dr.

  Universitätsklinikum Münster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Manager

CONTACT

+4922048306820; clinicaltrials.gov@miltenyi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose treatment with CAR T cell therapy in previous trial, long-term follow-up in this trial with cohorts: MB-CART20.1 Lymphoma, MB-CART20.1 Melanoma, MB-CART19.1 pediatric ALL and progressive NHL, MB-CART19.1 adult ALL, MB-CART19.1 adult NHL/CLL, MB-CART2019.1 Lymphoma

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 18, 2024
• Study Start: May 5, 2024
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040
• Last Updated: November 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)