A Phase I Study of Mana 312 T Cells Given After Stem Cell Transplantation in People with Acute Myeloid Leukemia or Myelodysplastic Syndromes

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Phase 1 Study of Escalating Single and Multiple Doses of Mana 312 (Multi Tumor-Associated Antigen T cells) Administered to Adult Subjects with Acute Myeloid Leukemia or Myelodysplastic Syndrome after Allogeneic Hematopoietic Stem Cell Transplant

Purpose

The purpose of this study is to find the best dose of an investigational treatment called Mana 312 that can be given in patients who receive a donated (allogeneic) stem cell transplant as treatment for acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Mana 312 is a type of cellular therapy made in a laboratory from healthy donated T cells, a type of immune cell (from the same donor used for the patient’s transplant). It is hoped that Mana 312 will enhance the effectiveness of the transplant and reduce the chance that a patient’s disease will come back.

Patients in this study will either receive Mana 312 cells two to three months after their transplant, one year after their transplant, or when their cancer comes back, depending on the status of the study. Mana 312 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have AML or MDS and have had or be planning to have an allogeneic stem cell transplant.
  • Each patient’s stem cell donor must also be willing to donate T cells to make Mana 312 for the patient.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roni Tamari at 646-608-3738.

Protocol

21-069

Phase

I

Investigator

Co-Investigators