drugset / Trial / NCT05350163

T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

NCT05350163 ↗

Phase 1 Terminated 11 enrolled Guenther Koehne
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT). This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.

Timeline

Start
2022-04-05
Primary completion
2023-09-18
Completion
2023-09-18

Outcome

Outcome not reported

Stopped: “The study met criteria for stopping due to lack of efficacy per protocol specifications.”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Cell therapy 100000 cells/kg —
Subject T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Cell therapy 500000 cells/kg —
Subject T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Cell therapy 1e+06 cells/kg —
Subject T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Cell therapy 2e+06 cells/kg —