Long-Term Follow-Up Clinical Trial of Subjects Treated with PRAME TCR modified T cells, MDG1011

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000717-20-DE

Enrollment

Registered

2019-07-19

Start date

2019-10-09

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Myeloid and Lymphoid Neopolasms MedDRA version: 20.0 Level: PT Classification code 10061240 Term: Malignant lymphoid neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ

Interventions

Product Code: MDG1011 Pharmaceutical Form: Dispersion for infusion INN or Proposed INN: 11 Structurally Diverse Substance - Cell therapy Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Treated with MDG1011 in a Medigene sponsored clinical trial whether completed or not. - Signed informed consent for this Long-term Follow-up clinical trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects who received their last treatment with MDG1011 more than 15 years before the first visit of this Long-term Follow-Up clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the long-term safety in subjects who were treated with MDG1011 during participation in a parental clinical trial (Eudract number 2017-000440-18). Delayed onset of treatment-related AEs and the clinical outcome of treatment-related AEs that started in the parental clinical trial and were ongoing at the time of enrollment into this clinical trial will be monitored. ;Secondary Objective: The secondary objectives are to evaluate the overall survival and to monitor the occurrence of Replication Competent Retrovirus (RCR) in subjects treated with MDG1011. ; Primary end point(s): Persisting or delayed adverse events suspected to be related to treatment with MDG1011 (Adverse Drug Reactions, ADR) observed up to 15 years after treatment considering but not limited to: - New malignancies - Neurological disorders - Rheumatologic and autoimmune disorders - Haematological disorders - Genotoxicity ;Timepoint(s) of evaluation of this end point: up to 15 years after treatment	—

Measure

Time frame

Main Objective: The primary objective is to assess the long-term safety in subjects who were treated with MDG1011 during participation in a parental clinical trial (Eudract number 2017-000440-18). Delayed onset of treatment-related AEs and the clinical outcome of treatment-related AEs that started in the parental clinical trial and were ongoing at the time of enrollment into this clinical trial will be monitored. ;Secondary Objective: The secondary objectives are to evaluate the overall survival and to monitor the occurrence of Replication Competent Retrovirus (RCR) in subjects treated with MDG1011. ; Primary end point(s): Persisting or delayed adverse events suspected to be related to treatment with MDG1011 (Adverse Drug Reactions, ADR) observed up to 15 years after treatment considering but not limited to: - New malignancies - Neurological disorders - Rheumatologic and autoimmune disorders - Haematological disorders - Genotoxicity ;Timepoint(s) of evaluation of this end point: up to 15 years after treatment

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: SAE and AESI up to 2 years after treatment Overall survival up to 15 years after treatment ; Secondary end point(s): - Serious adverse events (SAE) and adverse events of special interest (AESI) up to 2 years after treatment - Overall survival observed up to 15 years after treatment with MDG1011 - Evaluation of the number and proportion of symptomatic subjects with detectable RCR.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: SAE and AESI up to 2 years after treatment Overall survival up to 15 years after treatment ; Secondary end point(s): - Serious adverse events (SAE) and adverse events of special interest (AESI) up to 2 years after treatment - Overall survival observed up to 15 years after treatment with MDG1011 - Evaluation of the number and proportion of symptomatic subjects with detectable RCR.

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Countries

Germany

Contacts

Public ContactStephanie Koelbl

Medigene AG

s.koelbl@medigene.com+49892000333420

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026