Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Acute Myelogenous Leukemia (AML) | Acute Myeloid Leukemia | ALIAS | 0.85 |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single FT1050 treated UCB unit | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single FT1050 treated UCB Unit
- description
- Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
- interventionNames
- Biological: Single FT1050 treated UCB unit
Primary outcomes (1)
- measure
- Neutrophil engraftment/chimerism
- timeFrame
- Day 42
- 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.
Secondary outcomes (3)
- measure
- Safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
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