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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:June 2016
End Date:June 2020
Contact:Monica Diaz
Email:monica.diaz@fatetherapeutics.com

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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
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

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
procedures.

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
disease;

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
patient.
We found this trial at
15
sites
Duarte, California 91010
Principal Investigator: Chatchada Karanes, MD
Phone: 626-218-0061
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Michael Bishop
Phone: 773-834-0982
University of Chicago One of the world's premier academic and research institutions, the University of...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Principal Investigator: Abhinav Deol, MD
Phone: 313-576-9271
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Richard Maziarz, MD
Phone: 503-494-2166
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Birmingham, Alabama 35294
Principal Investigator: Ayman Saad, MD
Phone: 205-996-8023
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Corey Cutler, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Cincinnati, Ohio 45236
Principal Investigator: James Essell, MD
Phone: 513-751-2273
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Cincinnati, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Hannah Choe, MD
Phone: 614-685-7035
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Indianapolis, Indiana 46237
Principal Investigator: John R Edwards, MD
Phone: 317-528-5500
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Carlos Bachier, MD
Phone: 615-524-4174
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New York, New York 10065
Principal Investigator: Koen Van Besien, MD
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: John McCarty, MD
Phone: 804-828-4732
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Daniel Couriel, MD
Phone: 801-587-4756
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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San Antonio, Texas 78229
Principal Investigator: Cesar Freytes, MD
Phone: 210-575-4281
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3855 Health Sciences Drive
San Diego, California 92093
Principal Investigator: Dimitrios Tzachanis, MD
Phone: 858-822-1921
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