Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT03503968
Brief Summary:
This is a multicentre, non-randomized, open-label, Phase I/II clinical trial of MDG1011, an investigational medicinal product (IMP), consisting of patient-derived autologous T cells, persistently transduced with a Preferentially Expressed Antigen in Melanoma (PRAME)-specific human leukocyte antigen (HLA)-A\*02:01-restricted T cell receptor (TCR).
Detailed Description:
Phase I:
The Phase I dose escalation part will establish the MTD/RP2D in subjects with high risk myeloid and lymphoid neoplasms, a total of 3 disease entities.
Phase I subjects will be enrolled into the following cohorts and treated with a single intravenous (i.v.) infusion of IMP:
* Cohort 1: target dose of 1 x 105 T cells/kg ± 20%
* Cohort 2: target dose of 1 x 106 T cells/kg ± 20%
* Cohort 3: target dose of 5 x 106 T cells/kg ± 20%
* Optional cohort 4: up to 1 x 107 T cells/kg + 20%
Phase II:
The Phase II part consists of two arms, each representing one disease entity. Within each arm, representing a disease entity, subjects will be enrolled in 2 different treatment groups to receive either:
1. IMP in the treatment group (up to 20 subjects who are positive for human leukocyte antigen (HLA)-A\*02:01); Or
2. therapy as per Investigator's discretion in the concurrent control (up to 20 subjects who are negative for HLA-A\*02:01).
Study:
NCT03503968
Study Brief:
Protocol Section:
NCT03503968