Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit

In brief

This trial is a prospective, open-label, single-arm trial of the safety of a single FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity conditioning regimen for hematologic malignancies. A maximum of 40 eligible adult subjects will be enrolled and treated in the trial at approximately 2-4 centers within the U.S.

Key facts

Study ID: NCT01527838
Run by: Fate Therapeutics
People needed: 10
Starts: 2012-01-01
Expected to finish: 2013-11-01
Last updated by the study team: 2016-09-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)
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.
Age 18-65 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Signed IRB approved Informed Consent Form (ICF).

You may not qualify if…

The following hematologic malignancies are excluded:
Myelofibrosis (Agnogenic Myeloid Metaplasia)
Aplastic anemia.
Previous treatment that included an allogeneic transplant
Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular
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.
Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected for hemoglobin.
Renal disease: serum creatinine > 2.0 mg/dl and calculated creatinine clearance < 40 mL/min
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.
Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation.
HIV antibody.
Uncontrolled infection.
Pregnancy or breast feeding mother.
Inability to comply with the requirements for care after allogeneic stem cell transplantation.
Participation in a concurrent clinical trial with a novel, unapproved investigational agent < 30 days prior to Day 0.

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States
Dana Farber Cancer Institute-Hematopoietic Stem Cell Transplant Program — Boston, Massachusetts, United States
Ohio State Univeristy Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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