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OncoMatch/Clinical Trials/NCT05088356

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

Is NCT05088356 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for allogeneic hematopoietic cell transplantation (hct).

Phase 1RecruitingStanford UniversityNCT05088356Data as of May 2026

Treatment: Purified regulatory T-cells (Treg) plus CD34+ HSPC · Fludarabine · Melphalan · CliniMACS CD34 Reagent System · Tacrolimus · Cyclophosphamide · Plerixafor · Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent · Thiotepa · Mycophenolate Mofetil (MMF) · RuxolitinibReduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Lab requirements

Kidney function

Calculated creatinine clearance ≥ 50 mL/min or creatinine < 2.0 mg/dL

Liver function

SGPT and SGOT ≤ 3 x ULN, unless elevated secondary to disease; Total bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome may be included at the discretion of the PI or where hemolysis has been excluded)

Cardiac function

Left ventricular ejection fraction (LVEF) ≥ 45%

LVEF ≥ 45%; DLCO ≥ 50%; Calculated creatinine clearance ≥ 50 mL/min or creatinine < 2.0 mg/dL; SGPT and SGOT ≤ 3 x ULN, unless elevated secondary to disease; Total bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome may be included at the discretion of the PI or where hemolysis has been excluded)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Stanford University · Stanford, California

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