Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Davis UCLA
Dates
study started
completion around

Description

Summary

This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

Official Title

A Phase Ib Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft

Keywords

Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia, hematopoietic stem cell transplantation, matched related donor, matched unrelated donor, Leukemia, Myeloid Leukemia, Preleukemia, Hematologic Neoplasms, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoid Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Orca-T

Eligibility

Locations

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • UC Davis
    Sacramento California 95817 United States
  • City of Hope
    Duarte California 91010 United States
  • Stanford Health Care
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Orca Biosystems, Inc.
ID
NCT04013685
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 255 study participants
Last Updated