NCT05350163

T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

Phase I Dose Escalation of T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Following CD34+- Selected Allogeneic Stem Cell Transplantation From Related & Unrelated Donors in Patients With Lymphoid, Myeloid or Plasma Cell Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Guenther Koehne · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoid Leukemia, Acute
• Myeloid Malignancy
• Plasma Cell Tumor

Interventions

Type	Name	Description
BIOLOGICAL	T-cell Receptor α/β Depleted Donor Lymphocyte Infusions	T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

Timeline

• Start date: 2022-04-05
• Primary completion: 2023-09-18
• Completion: 2023-09-18
• First posted: 2022-04-28
• Last updated: 2024-12-10
• Results posted: 2024-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study