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

Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - Any
Start Date:June 2016
End Date:June 2020
Contact:Monica Diaz

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A Phase 1, Non-randomized, Open-Label/ Phase 2 Randomized, Blinded Study of ProTmune™ (ex Vivo Programmed Mobilized Peripheral Blood Cells)Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects With Hematologic Malignancies Patients With Hematologic Malignancies

This study is a Phase 1, Non-randomized, Open-label/Phase 2 Randomized, Blinded Study of
ProTmune (ex vivo programmed mobilized peripheral blood cells) Versus Non-programmed
mobilized peripheral blood cells for Allogeneic Hematopoietic Cell Transplantation (HCT) in
Adult Subjects Aged 18 years and older with Hematologic Malignancies. A maximum of 70 total
eligible subjects will be enrolled and treated in the trial at approximately 15-20 centers in
the US and EU.

Key Inclusion Criteria:

1. Male and female patients aged 18 years and older, inclusive;

2. 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:

1. Acute myeloid leukemia

2. Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history
of marrow involvement

3. Myelodysplatic Syndrome

4. Chronic Myelogenous leukemia

3. Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;

4. mBP donor collection that meets protocol specifications;

5. Adequate performance status, defined as Karnofsky score greater than 70%;

6. For female patients of childbearing potential, all of the following criteria must be

- 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

7. For male patients, agreement to use condoms with spermicide during sexual intercourse
from screening to the end of study; and

8. 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

Key Exclusion Criteria:

1. Phase 1 only: known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 2
or greater;

2. Positive serology for human immunodeficiency virus (HIV) or human T-cell lymphotropic
virus (HTLV) at any time prior to enrollment;

3. Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical
symptoms despite therapy);

4. Prior autologous or allogeneic HCT;

5. 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;

6. Pulmonary disease, renal dysfunction, hepatic disease, cardiac disease, neurologic

7. Participation in another clinical trial involving an investigational product within 30
days prior to screening; or

8. 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
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