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

ConditionsJuvenile 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 Myeloid Leukemia, BCR-ABL1 PositiveRecurrent Blastic Plasmacytoid Dendritic Cell NeoplasmRecurrent Myelodysplastic SyndromeRefractory Blastic Plasmacytoid Dendritic Cell NeoplasmRefractory Myelodysplastic SyndromeAcute Undifferentiated LeukemiaMixed Phenotype Acute LeukemiaRecurrent Chronic Myeloid Leukemia, BCR-ABL1 PositiveRefractory Chronic Myeloid 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 LeukemiaLeukemiaChronic Myeloid Leukemia, BCR-ABL1 Positive
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 80
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

HLA-A*0201 positive and HA-1(H) negative (RS_1801284: G/G) or

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

    Given IV

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Treatment (CD4+ and CD8+ HA-1 TCR T cells)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Feasibility of manufacturing minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells

Proportion of subjects for whom a HA-1 TCR T cell product can be produced.

Time frame
At time of T cell infusion (at day 0)
2

Feasibility of administering minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells

Proportion of subjects for whom a HA-1 TCR T cell product can be administered.

Time frame
At time of T cell infusion (at day 0)
3

Incidence of dose-limiting toxicities of HA-1 T cell receptor (TCR) T cells

Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Time frame
Up to 12 weeks after T-cell infusion

Secondary outcomes

1

Duration of in vivo persistence of transferred HA-1 T cell receptor (TCR) CD4+ T cells in peripheral blood

Evaluated by tetramer and/or molecular tracking e.g. quantitative polymerase chain reaction (qPCR).

Time frame
Up to 1 year
2

Duration of in vivo persistence of transferred HA-1 T cell receptor (TCR) CD8+ T cells in peripheral blood

Evaluated by tetramer and/or molecular tracking e.g. qPCR.

Time frame
Up to 1 year
3

Presence, proportion and persistence of HA-1 T cell receptor (TCR) CD4+ T cells in the bone marrow

Evaluated by tetramer and/or molecular tracking e.g. qPCR.

Time frame
Up to 1 year
4

Presence, proportion and persistence of HA-1 T cell receptor (TCR) CD8+ T cells in the bone marrow

Evaluated by tetramer and/or molecular tracking e.g. qPCR.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

HighPass Bio, Inc.

Collaborator

PromiCell Therapeutics, Inc.

Collaborator

Source ClinicalTrials.gov
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