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HA-1-Specific TCR Memory T Cells for Recurrent Acute Leukemia After Stem Cell Transplant

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Study Aim

This study aims to evaluate the feasibility and safety of administering and manufacturing HA-1-specific T cell receptor memory T cells for adults with recurrent acute leukemia after a stem cell transplant.

What is being tested

CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR

+ Bone Marrow Aspiration

+ Biospecimen Collection

BiologicalProcedure
Who is being recruted

Blastic Plasmacytoid Dendritic Cell Neoplasm+35

+ Blast Crisis

+ Bone Marrow Diseases

Until 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2018
See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center
Study ContactFHCC Immunotherapy IntakeMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 23, 2018

Actual date on which the first participant was enrolled.

This study focuses on testing a new treatment approach for children and adults who have recurrent acute leukemia after receiving a type of bone marrow transplant known as allogeneic hematopoietic stem cell transplantation. The study aims to explore the use of special immune cells, called CD8+ and CD4+ T cells, that have been modified to target and attack leukemia cells more effectively. These modified T cells are designed to recognize a specific part of the leukemia cells called the HA-1 antigen. By targeting this antigen, the treatment hopes to reduce the recurrence of leukemia after transplant and improve the chances of lasting remission. Participants in this study first receive chemotherapy to lower their existing immune cells. After this, they receive the modified T cells through an intravenous (IV) infusion. The study evaluates whether it is possible to successfully produce and administer these modified T cells to patients. Additionally, it monitors any potential side effects, which are assessed using standardized criteria to ensure safety. Participants are closely monitored for 12 weeks initially and then at regular intervals for up to 15 years to assess the treatment's long-term effects and safety.

Official TitlePhase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)
NCT03326921
Principal SponsorFred Hutchinson Cancer Center
Study ContactFHCC Immunotherapy IntakeMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blastic Plasmacytoid Dendritic Cell NeoplasmBlast CrisisBone Marrow DiseasesCell Transformation, NeoplasticChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphomaLymphoproliferative DisordersMyelodysplastic SyndromesMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesSkin DiseasesSkin NeoplasmsPathological Conditions, Signs and SymptomsLeukemia, Biphenotypic, AcuteLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, ChronicHistiocytic Disorders, MalignantSkin and Connective Tissue DiseasesNeoplasm, ResidualHematologic NeoplasmsDisease AttributesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelomonocytic, JuvenileMyelodysplastic-Myeloproliferative DiseasesCarcinogenesis

Criteria

Inclusion Criteria: * Subject age 0-80 years at the time of enrollment. * Subject must express HLA-A\*0201 * Subject must have the HA-1(H) genotype (RS\_1801284: A/G, A/A) * Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either: * HLA-A\*0201 positive and HA-1(H) negative (RS\_1801284: G/G) or * HLA-A\*0201 negative * Subjects who are currently undergoing or who previously underwent allogeneic HCT for * Acute myeloid leukemia (AML) of any subtype * Acute lymphoid leukemia (ALL) of any subtype * Mixed phenotype/undifferentiated/any other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm * Chronic myeloid leukemia with a history of blast crisis and: * With relapse or refractory disease (\>= 5% marrow blasts, or circulating blasts) at any time after HCT * With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \< 5% marrow blasts by morphology, no circulating blasts on \>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT * Myelodysplastic syndrome (MDS) of any subtype * Chronic myelomonocytic leukemia (CMML) * Juvenile myelomonocytic leukemia (JMML) * Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old * Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion * Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol * A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status DONOR SELECTION INCLUSION * Donor age \>= 18 years * Donors must be able to give informed consent Exclusion Criteria: * Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI) * Fertile subjects unwilling to use contraception during and for 12 months after treatment * Subjects with a life expectancy of \< 3 months of enrollment from coexisting disease other than leukemia * Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and/or sustained significant improvement in GVHD severity * The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required DONOR SELECTION EXCLUSION * Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection * Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive lymphodepleting chemotherapy (e.g., fludarabine and cyclophosphamide or debulking regimens as specified in the protocol) ending 2-14 days prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells IV.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fred Hutch/University of Washington Cancer Consortium

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Recruiting
One Study Center