Recruiting PHASE1 INTERVENTIONAL 6-arm NCT05088356

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

Phase 1 Trial for Patients With Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells

Sponsor: Orca Biosystems, Inc.

Conditions Acute Leukemia Advanced Hematologic Malignancies Allogeneic Hematopoietic Cell Transplantation (HCT) Chronic Myelogenous Leukemia Myelodysplastic Syndromes Myeloproliferative Disorders

Interventions CliniMACS CD34 Reagent System Cyclophosphamide Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent Fludarabine Melphalan Mycophenolate Mofetil (MMF) Plerixafor Purified regulatory T-cells (Treg) plus CD34+ HSPC Ruxolitinib Tacrolimus Thiotepa

Updated 8 times since 2021 Last updated: Dec 13, 2025 Started: Sep 7, 2021 Primary completion: Nov 30, 2027 Completion: Nov 30, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05088356, this PHASE1 trial focuses on Acute Leukemia and Advanced Hematologic Malignancies and remains actively recruiting participants. Sponsored by Orca Biosystems, Inc., it has been updated 8 times since 2021, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

8 versions recorded

Jan 2026 — Present [monthly]

Recruiting PHASE1
Jul 2025 — Jan 2026 [monthly]

Recruiting PHASE1
Sep 2024 — Jul 2025 [monthly]

Recruiting PHASE1
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE1
Mar 2024 — Jul 2024 [monthly]

Recruiting PHASE1

▶ Show 3 earlier versions

Dec 2023 — Mar 2024 [monthly]

Recruiting PHASE1
Nov 2022 — Dec 2023 [monthly]

Recruiting PHASE1
Nov 2021 — Nov 2022 [monthly]

Recruiting PHASE1

First recorded

Sep 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Orca Biosystems, Inc.
Stanford University

Data source: Stanford University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Stanford, United States