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

Summary

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.

Conditions

• 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 Myeloid 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 Myeloid Leukemia, BCR-ABL1 Positive
• Refractory Chronic Myeloid 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
• Chronic Myeloid Leukemia, BCR-ABL1 Positive

Interventions

BIOLOGICAL

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

Given IV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

• HighPass Bio, Inc.

  collaborator UNKNOWN

• PromiCell Therapeutics, Inc.

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Elizabeth Krakow · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-23

Primary Completion

2027-10-16

Completion

2028-07-16

FDA Drug

Yes

Countries

• United States

Study Locations