ong-Term Follow-up of Patients Treated with Miltenyi Cell and Gene Therapies

Phase 1

Recruiting

• Conditions: nresectable stage III or IV melanoma, Relapsed or refractory CD19 positive B cell malignancies (adult ALL, adult NHL/chronic lymphatic leukemia [CLL]), Relapsed or refractory CD19 positive B cell malignancies (pediatric acute lymphatic leukemia [ALL], aggressive NHL), Relapsed or refractory CD20 positive B-cell non-Hodgkin’s lymphoma (NHL), Relapsed or refractory B cell non-Hodgkins lymphoma (NHL); MedDRA version: 21.0Level: LLTClassification code: 10063625Term: Acute lymphoblastic leukemia recurrent Class: 10029104; MedDRA version: 21.0Level: PTClassification code: 10003902Term: B-cell lymphoma recurrent Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10027152Term: Melanoma of skin (malignant) Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10008978Term: Chronic lymphocytic leukemia refractory Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10008977Term: Chronic lymphocytic leukemia recurrent Class: 10029104; MedDRA version: 21.0Level: PTClassification code: 10003903Term: B-cell lymphoma refractory Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2022-501648-14-00
• Lead Sponsor: Miltenyi Biomedicine GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patient underwent treatment with a Miltenyi CAR T cell therapy 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 are defined for this long-term follow-up trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate long-term safety after treatment with Miltenyi CAR T cell therapy;Secondary Objective: To further assess safety concerning blood count, growth and development of pediatric patients and occurrence of replication competent lentivirus after Miltenyi CAR T cell therapy, To evaluate long-term treatment efficacy of surviving patients as measured by status of disease progression and survival status over time and to evaluate persistence of the transgene;Primary end point(s): 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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):B- and T-lymphocyte count;Secondary end point(s):Height and weight, Tanner staging, menstruation status for pediatric patients;Secondary end point(s):Percentage of patients with detectable replication-competent lentivirus (RCL) (if results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient; if results of all samples in first year of primary trial were negative for an individual patient, sampling will not be continued for this patient in this long-term follow-up trial);Secondary end point(s):Percentage of patients who relapse or progress since enrollment and rate of surviving patients;Secondary end point(s):Percentage of patients with detectable transgene levels (if results of 2 consecutive years are negative for an individual patient, further sampling will be stopped for this patient)