RECRUITING

HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant

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Conditions

Juvenile Myelomonocytic LeukemiaRecurrent Acute Biphenotypic LeukemiaRecurrent Acute Undifferentiated LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRefractory Acute Lymphoblastic LeukemiaRefractory Adult Acute Lymphoblastic LeukemiaBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecurrent Blastic Plasmacytoid Dendritic Cell NeoplasmRecurrent Myelodysplastic SyndromeRefractory Blastic Plasmacytoid Dendritic Cell NeoplasmRefractory Myelodysplastic SyndromeAcute Undifferentiated LeukemiaMixed Phenotype Acute LeukemiaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRefractory Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecurrent Acute Lymphoblastic LeukemiaRecurrent Acute Myeloid LeukemiaMyelodysplastic SyndromeAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaAcute Biphenotypic LeukemiaChronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaMinimal Residual DiseaseRecurrent Chronic Myelomonocytic LeukemiaRecurrent Mixed Phenotype Acute LeukemiaLeukemiaHA-1TCRImmunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.

Official Title

Phase 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)

Quick Facts

Study Start:2018-02-23
Study Completion:2028-07-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03326921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient age 0-75 years at the time of enrollment.
  2. * Patients must express HLA-A\*0201
  3. * Patients must have the HA-1(H) genotype (RS_1801284: A/G, A/A)
  4. * Patients 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:
  5. * HLA-A\*0201 positive and HA-1(H) negative (RS_1801284: G/G) or
  6. * HLA-A\*0201 negative
  7. * Patients who are currently undergoing or who previously underwent allogeneic HCT for
  8. * Acute myeloid leukemia (AML) of any subtype
  9. * Acute lymphoid leukemia (ALL) of any subtype
  10. * Mixed phenotype/undifferentiated/any other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm
  11. * Chronic myeloid leukemia with a history of blast crisis and:
  12. * With relapse or refractory disease (\>= 5% marrow blasts, or circulating blasts) at any time after HCT
  13. * 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
  14. * Myelodysplastic syndrome (MDS) of any subtype
  15. * Chronic myelomonocytic leukemia (CMML)
  16. * Juvenile myelomonocytic leukemia (JMML)
  17. * Patients 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 patients younger than 18 years old
  18. * Patients 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
  19. * Patients who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol
  20. * 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 patients with low performance status
  21. * Donor age \>= 18 years
  22. * Donors must be able to give informed consent
  23. * Patients 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:
  24. * HLA-A\*0201 positive and HA-1(H) negative (RS_1801284: G/G) or
  25. * HLA-A\*0201 negative
  1. * Medical or psychological conditions that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)
  2. * Fertile patients unwilling to use contraception during and for 12 months after treatment
  3. * Patients with a life expectancy \< 3 months of enrollment from coexisting disease other than leukemia
  4. * Patients who develop grade IV acute GVHD or severe chronic GVHD following most recent transplant prior to enrollment on the protocol
  5. * The presence of organ toxicities will not necessarily exclude patients 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
  6. * Donors who are HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection
  7. * Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an NMDP-affiliated and qualified donor center and are facilitated by the NMDP.

Contacts and Locations

Study Contact

FHCC Immunotherapy Intake
CONTACT
206-606-4668
immunotherapy@fredhutch.org
FHCC Immunotherapy Intake
CONTACT
855-557-0555

Principal Investigator

Elizabeth Krakow
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Fred Hutchinson Cancer Center

  • Elizabeth Krakow, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-23
Study Completion Date2028-07-16

Study Record Updates

Study Start Date2018-02-23
Study Completion Date2028-07-16

Terms related to this study

Keywords Provided by Researchers

  • HA-1
  • TCR
  • Immunotherapy
  • Leukemia

Additional Relevant MeSH Terms

  • Juvenile Myelomonocytic Leukemia
  • Recurrent Acute Biphenotypic Leukemia
  • Recurrent Acute Undifferentiated Leukemia
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Adult Acute Lymphoblastic Leukemia
  • Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Recurrent Myelodysplastic Syndrome
  • Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Refractory Myelodysplastic Syndrome
  • Acute Undifferentiated Leukemia
  • Mixed Phenotype Acute Leukemia
  • Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Biphenotypic Leukemia
  • Chronic Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Minimal Residual Disease
  • Recurrent Chronic Myelomonocytic Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia
  • Leukemia