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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-05

Study Completion Date

2040-12-31

Brief Summary

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

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Long-term follow-up of CAR T cell therapy

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

Group Type EXPERIMENTAL

MB-CART19.1

Intervention Type BIOLOGICAL

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

MB-CART20.1

Intervention Type BIOLOGICAL

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

MB-CART2019.1

Intervention Type BIOLOGICAL

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

Interventions

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MB-CART19.1

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

Intervention Type BIOLOGICAL

MB-CART20.1

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

Intervention Type BIOLOGICAL

MB-CART2019.1

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

Intervention Type BIOLOGICAL

Other Intervention Names

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CD19-targeting CAR T cells Anti-CD19 CAR T cells CD20-targeting CAR T cells Anti-CD20 CAR T cells CD20/CD19-targeting CAR T cells Anti-CD20/CD19 CAR T cells

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No