drugset / Trial / NCT03326921
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Phase 1
Recruiting
24 enrolled
Fred Hutchinson Cancer Center
HighPass Bio, Inc. · collabPromiCell Therapeutics, Inc. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-02-23
- Primary completion
- 2027-10-16
- Completion
- 2028-07-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HA-1 TCR T Cells | Cell therapy | — | Intravenous |
Indications
CD4+/CD56+ hematodermic neoplasm
acute biphenotypic leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia
blast phase chronic myelogenous leukemia, BCR-ABL1 positive
childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia
juvenile myelomonocytic leukemia
myelodysplastic syndrome