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A Phase I Trial of a Single FT1050 (16,16-Dimethyl Prostaglandin E2) Ex Vivo-Modulated Umbilical Cord Blood (CB) Unit Following a Reduced Intensity Conditioning Regimen For Adults With Hematologic Malignancies


Phase 1
18 Years
65 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease, Chronic Lymphocytic Leukemia (CLL), Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)

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Trial Information

A Phase I Trial of a Single FT1050 (16,16-Dimethyl Prostaglandin E2) Ex Vivo-Modulated Umbilical Cord Blood (CB) Unit Following a Reduced Intensity Conditioning Regimen For Adults With Hematologic Malignancies


The trial will be conducted in three sequential cohorts of 6-12 evaluable subjects each.

Cohort 1 will enroll eligible subjects for whom a single CB unit has been identified that
meets the minimum HLA-matching criteria and has a minimum pre-cryopreservation total
nucleated cell (TNC) dose of at least 2.5 x 10^7 cells/kg. Cohort 2 is identical to Cohort
1, except that the TNC dose of the CB unit must be between 2.0 - <2.5 x 10^7 cells/kg.
Finally, Cohort 3 is identical to Cohort 2, except that the TNC dose of the CB unit must be
between 1.5 - <2.0 x 10^7 cells/kg. If no safety rules are triggered, the study will
proceed to the next dosing cohort. Within a dosing cohort, no more than three subjects may
be before Day 42 at any one time, unless they have already engrafted neutrophils. The final
dosing cohort is defined as the last cohort where 12 evaluable subjects are treated and no
stopping rules are triggered. The corresponding TNC dose level will be considered the
minimally acceptable TNC dose level.


Inclusion Criteria:



1. Subjects with hematologic malignancies for whom allogeneic stem cell transplantation
is deemed clinically appropriate. Eligible diseases and stages include:

- Non-Hodgkin's lymphoma or Hodgkin's lymphoma

- Chronic lymphocytic leukemia (CLL)

- Acute myelogenous leukemia (AML)

- Chronic myelogenous leukemia (CML)

2. Lack of 5-6/6 HLA-matched related or 8/8 HLA-A, B, C, DRß1 matched unrelated donor;
or unrelated donor not available within appropriate timeframe.

- Identification of suitable backup CB unit(s) (single unit with
pre-cryopreservation cell dose ≥ 2.5 x 10^7 TNC/kg or two units with
pre-cryopreservation cell dose ≥ 1.5 x 10^7 TNC/kg each) and meeting minimum HLA
match criteria.

- An acceptable alternative to one or two backup CB unit(s) is the identification
of an eligible related haploidentical donor that meets minimum HLA match
criteria.

3. Age 18-65 years.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

5. Signed IRB approved Informed Consent Form (ICF).

Exclusion Criteria:

1. The following hematologic malignancies are excluded:

- Myelofibrosis (Agnogenic Myeloid Metaplasia)

- Aplastic anemia.

2. Previous treatment that included an allogeneic transplant

3. Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular

4. dysfunction (Ejection fraction < 40%) as measured by gated radionucleotide
ventriculogram or echocardiogram; active angina pectoris, or uncontrolled
hypertension; history of myocardial infarction with depressed ejection fraction.

5. Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic
restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected for
hemoglobin.

6. Renal disease: serum creatinine > 2.0 mg/dl and calculated creatinine clearance < 40
mL/min

7. Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's
syndrome or ongoing hemolytic anemia), SGOT or SGPT > 3 x upper limit of normal.

8. Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
neuropsychiatric abnormalities believed to preclude transplantation.

9. HIV antibody.

10. Uncontrolled infection.

11. Pregnancy or breast feeding mother.

12. Inability to comply with the requirements for care after allogeneic stem cell
transplantation.

13. Participation in a concurrent clinical trial with a novel, unapproved investigational
agent < 30 days prior to Day 0.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Neutrophil engraftment/chimerism

Outcome Description:

To determine the minimally effective TNC dose for a single FT1050-treated CB unit based on neutrophil engraftment/chimerism when used for hematopoietic reconstitution following a reduced-intensity conditioning regimen for hematologic malignancies.

Outcome Time Frame:

Day 42

Safety Issue:

No

Principal Investigator

Pratik Multani, MD

Investigator Role:

Study Director

Investigator Affiliation:

Fate Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

FT1050-02

NCT ID:

NCT01527838

Start Date:

January 2012

Completion Date:

October 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma (NHL)
  • Hodgkin's Disease
  • Chronic Lymphocytic Leukemia (CLL)
  • Acute Myelogenous Leukemia (AML)
  • Acute Lymphoblastic Leukemia (ALL)
  • Hematologic malignancies
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Hematologic Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer Institute-Hematopoietic Stem Cell Transplant ProgramBoston, Massachusetts  02215
Ohio State Univeristy Comprehensive Cancer CenterColumbus, Ohio  43210