A study of TCR engineered donor T Cells in leukemia patients

The research company TScan Therapeutics, Inc is conducting the clinical trial: a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor.

It is planned to include 63 participants.

Actual study start date is July 2022. The researchers expect to complete the study by June 2025.

One primary outcome measure is Primary, Incidence of DLTs Incidence of AEs and SAEs of TSC100 and TSC101 combined with the SOC compared with the SOC alone at 2 years of follow-up.

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05473910.