Trials / Active Not Recruiting
Active Not RecruitingNCT04013685
Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 255 (estimated)
- Sponsor
- Orca Biosystems, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Myelodysplastic Syndromes
- Acute Leukemia
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- Chronic Myeloid Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Orca-T | an allogeneic stem cell and T-cell immunotherapy biologic |
Timeline
- Start date
- 2019-11-21
- Primary completion
- 2025-04-30
- Completion
- 2027-04-01
- First posted
- 2019-07-10
- Last updated
- 2025-05-02
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04013685. Inclusion in this directory is not an endorsement.