- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01527838
Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02214
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute-Hematopoietic Stem Cell Transplant Program
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Ohio State Univeristy Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single FT1050 treated UCB Unit
Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
|
Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neutrophil engraftment/chimerism
Time Frame: Day 42
|
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.
|
Day 42
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: Day 100
|
Define the safety profile of treatment with a single FT1050-treated CB unit.
To define the preliminary efficacy of treatment with a single FT1050-treated CB unit.
|
Day 100
|
Immune reconstitution
Time Frame: 2 years
|
To assess immune reconstitution (B-, T-, and NK-cells).
|
2 years
|
Donor search
Time Frame: Day 0
|
To determine time from the initiation of donor search to transplantation.
|
Day 0
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Samuel Dychter, MD, Fate Therapeutics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia, B-Cell
- Lymphoma
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphocytic, Chronic, B-Cell
Other Study ID Numbers
- FT1050-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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