Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies

Key Inclusion Criteria:

• Male and female patients aged 18 years and older, inclusive;
• Patients must have a hematologic malignancy for which allogeneic hematopoietic peripheral blood cell transplantation is deemed clinically appropriate.

Eligible diseases and stages include the following:

• Acute myeloid leukemia
• Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history of marrow involvement
• Myelodysplastic Syndrome
• Chronic myelogenous leukemia
• Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;
• mBP donor collection that meets protocol specifications;
• Adequate performance status, defined as Karnofsky score greater than or equal to 70%;
• For female patients of childbearing potential, all of the following criteria must be met:

• They are not pregnant (i.e., female patients must have a negative serum pregnancy test at screening);
• They are not breastfeeding;
• They do not plan to become pregnant during the study; and
• They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile.
• For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
• Willingness and ability to sign an IRB/IEC-approved ICF before performance of any study-specific procedures or tests and to comply with protocol visits, and study procedures.

Key Exclusion Criteria:

• Phase 1 only: Known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 3 (severe) or greater;
• Positive serology for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) at any time prior to enrollment;
• Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms despite therapy);
• Prior autologous or allogeneic HCT;
• Active malignancy, other than the one for which the allogeneic mPB transplant is being performed, within 12 months of enrollment, excluding superficial basal cell and carcinoma in situ cervical cancer;
• Pulmonary disease, renal dysfunction, hepatic disease, cardiac disease, neurologic disease;
• Participation in another clinical trial involving an investigational product within 30 days prior to screening; or
• Any condition or therapy, which, in the opinion of the Investigator, might pose a risk to the patient or make participation in the study not in the best interest of the patient.