Summary

for people ages 18-70 (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Dimitrios Tzachanis

Description

Summary

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 to 70 years 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.

Official Title

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

Keywords

Hematologic Malignancies Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia Cell Transplants Hematopoietic Cell Transplant HSCT Hematologic Malignancy ALL AML Myelodysplastic Syndrome MDS Allogeneic CML Stem Cell Transplant Transplant Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Preleukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive ProTmune Control Arm

Eligibility

For people ages 18-70

Key Inclusion Criteria:

  1. Male and female patients aged 18 to 70 years, 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
  5. Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;
  6. mBP donor collection that meets protocol specifications;
  7. Adequate performance status, defined as Karnofsky score greater than 70%;
  8. For female patients of childbearing potential, all of the following criteria must be met:
  9. They are not pregnant (i.e., female patients must have a negative serum pregnancy test at screening);
  10. They are not breastfeeding;
  11. They do not plan to become pregnant during the study; and
  12. They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile
  13. For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
  14. 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.

Locations

  • University of California, San Diego (UCSD) Moores Cancer Center accepting new patients
    San Diego California United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist

  • Dimitrios Tzachanis
    Assistant Clinical Professor, Medicine. Authored (or co-authored) 30 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Fate Therapeutics
ID
NCT02743351
Phase
Phase 1/2
Study Type
Interventional
Last Updated