TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms

Summary

Participation Requirements

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 ...

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: IMP in the treatment group (up to 20 subjects who are positive for human leukocyte antigen (HLA)-A*02:01); Or therapy as per Investigator's discretion in the concurrent control (up to 20 subjects who are negative for HLA-A*02:01).

Tracking Information