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Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell

Phase 1-2 Trial for Patients With Advanced Hematologic Malignancies Undergoing Myeloablative Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells

NCT01660607•Stanford University

View on ClinicalTrials.gov

Summary

This study looks at giving specific types of immune cells, called regulatory T cells and conventional T cells, to patients with blood cancers who are receiving a stem cell transplant. These cells are added back to help the immune system recover and reduce complications after the transplant.

Detailed Description

Primary Objectives: * To determine the efficacy, safety and feasibility of administration of several dose combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors (related or unrelated) using a T cell depleted graft \[CD34+ hematopoietic progenitor cells ("CD34+ HSPC")\], without immune suppression. * To determine if concomitant single-agent immunosuppression is needed with fresh Treg cells (phase 2 stage 1) \* To determine 1-year GvHD-free relapse-free survival (GRFS) post-HCT (phase 2 stage 2). Secondary Objectives: * To determine the 1 year OS in patients undergoing allogeneic HCT with matched donors. * To measure the incidence and severity of acute and chronic graft vs host disease (GvHD) * To measure incidence of serious infections

Eligibility

Age

13 - 73 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with the following diseases that are histopathologically confirmed are eligible
•* Acute leukemia, primary refractory or beyond CR1, or minimal residual disease (MRD) positivity.
•* High risk acute myeloid leukemia in CR1 with any of the following features:
•* Complex karyotype(≥3 clonal chromosomal abnormalities)
•* Any of the following high risk chromosomal abnormalities:
•* Monosomal karyotype (-5, 5q-, -7, 7q-)
•* t(11q23), t(9;11), inv(3), t(3;3) t(6;9) t(9;22)
•* Normal karyotype with fms-like tyrosine kinase 3 (FLT3)-ITD mutation
•* Other high risk features as determined by molecular studies, or clinical presentation as assessed by the treating physician
•* Chronic myelogenous leukemia (accelerated, blast or second chronic phase)
+22 more criteria

Exclusion Criteria

•1. Seropositive for any of the following:
•HIV ab; hepatitis B sAg; hepatitis C ab
•2. Prior myeloablative therapy or hematopoietic cell transplant
•3. Candidate for autologous transplant
•4. HIV positive
•5. Active uncontrolled bacterial, viral or fungal infection, defined as currently taking antimicrobial therapy and progression of clinical symptoms.
•6. Uncontrolled central nervous system (CNS) disease involvement
•7. Pregnant or a lactating female
•8. Positive serum or urine beta human chorionic gonadotropin (HCG) test in females of childbearing potential within 3 weeks of registration
•9. Psychosocial circumstances that preclude the patient being able to go through transplant or participate responsibly in follow up care
+4 more criteria

Locations (1)

Stanford University School of Medicine Palo Alto, California, United States

Palo Alto, California, United States

Key Dates

Start Date

February 9, 2012

Primary Completion Date

December 20, 2023

Completion Date

December 20, 2023

Last Updated

August 19, 2025

Enrollment

ACTUAL participants

Conditions

Myeloid Leukemia, ChronicAcute Myelogenous LeukemiaMyelodysplastic Syndromes (MDS)Lymphoma, Non-HodgkinAcute Lymphoblastic Leukemia (ALL)Myeloproliferative SyndromeAcute Myeloid LeukemiaAcute LeukemiaChronic Myelogenous Leukemia

Interventions

CD34+ Hematopoietic Progenitor Cells (HSPC)

BIOLOGICAL

Regulatory T-Cells (Treg)

BIOLOGICAL

Conventional T-Cells (Tcon)

BIOLOGICAL

Myeloablative Conditioning Regimen

PROCEDURE

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

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RECRUITING

Correlation of Venetoclax Plasma Concentrations With Toxicity of Hypometilating Agents and Venetoclax Combination for Acute Myeloid Leukemia Patients in Remission.

NCT07254312

AML (Acute Myelogenous Leukemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Correlation of Venetoclax Plasma Concentrations With Toxicity of Hypometilating Agents and Venetoclax Combination for Acute Myeloid Leukemia Patients in Remission.

HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy

Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies