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

Phase 1

• Conditions: MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851; MedDRA version: 20.0 Level: LLT Classification code 10028557 Term: Myeloid leukemia, acute System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); 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: HLT Classification code 10028536 Term: Myelodysplastic syndromes System Organ Class: 100000004851; MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000717-20-DE
• Lead Sponsor: Medigene AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 52

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

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

Study & Design

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