Spots Global Cancer Trial Database for TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms

Study Description

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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial