ClinicalTrialsFinder
RecruitingPhase 1NCT03326921

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

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)

Sponsor

Fred Hutchinson Cancer Center

Enrollment

24 participants

Start Date

Feb 23, 2018

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myeloid LeukemiaMyelodysplastic SyndromeMinimal Residual DiseaseLeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent Myelodysplastic SyndromeRefractory Myelodysplastic SyndromeRecurrent Blastic Plasmacytoid Dendritic Cell NeoplasmRefractory Blastic Plasmacytoid Dendritic Cell NeoplasmChronic Myelomonocytic LeukemiaRefractory Acute Lymphoblastic LeukemiaMixed Phenotype Acute LeukemiaRecurrent Acute Lymphoblastic LeukemiaJuvenile Myelomonocytic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRecurrent Mixed Phenotype Acute LeukemiaRecurrent Acute Biphenotypic LeukemiaAcute Undifferentiated LeukemiaRecurrent Acute Undifferentiated LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveRecurrent Childhood Acute Lymphoblastic LeukemiaAcute Biphenotypic LeukemiaRefractory Adult Acute Lymphoblastic LeukemiaBlast Phase Chronic Myeloid Leukemia, BCR-ABL1 PositiveRecurrent Chronic Myeloid Leukemia, BCR-ABL1 PositiveRefractory Chronic Myeloid Leukemia, BCR-ABL1 Positive

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.

Eligibility

Max Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy — where T cells (immune cells) from a donor are engineered to recognize and attack a specific target called HA-1 found on leukemia cells — for patients whose acute leukemia has returned or is not responding after a bone marrow transplant. **You may be eligible if...** - You are between 0 and 80 years old - Your leukemia has come back or is not responding after a bone marrow (stem cell) transplant - You carry a specific gene variant called HLA-A*0201 and HA-1(H) - You have a suitable stem cell donor available **You may NOT be eligible if...** - You do not carry the required genetic markers (HLA-A*0201 or HA-1(H)) - You do not have a suitable donor - Your organ function is too poor for the treatment - You have uncontrolled infection or other serious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR

Given IV

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBiospecimen Collection

Undergo blood sample collection

Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03326921

Related Trials

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

NCT05564390346 locations

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

NCT05554406220 locations

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

NCT05554393177 locations

Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

NCT06317649220 locations

Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

NCT052379863 locations