Clinical Trials /

Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

NCT04260698

Description:

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
  • Official Title: An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Clinical Trial IDs

  • ORG STUDY ID: GC P#07.01.020
  • NCT ID: NCT04260698

Conditions

  • Hematological Malignancies

Interventions

DrugSynonymsArms
omidubicelNiCordomidubicel

Purpose

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Detailed Description

      Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient
      number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone
      marrow and regenerating a full array of hematopoietic cell lineages with early and late
      repopulating ability in a timely fashion.

      Omidubicel is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic
      cells from one entire unit of umbilical cord blood. Omidubicel utilizes the small molecule
      nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the
      migration, bone marrow (BM) homing and engraftment efficiency of hematopoietic progenitor
      cells (HPC) expanded in ex vivo cultures.

      The overall study objectives are to provide access to omidubicel for transplantation in
      patients with hematological malignancies and to collect additional safety and efficacy data.
    

Trial Arms

NameTypeDescriptionInterventions
omidubicelExperimentalOmidubicel is a cryopreserved stem/progenitor cell based product comprised of: Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF)) the non-cultured cell fraction of the same Cord Blood Unit (CBU) (Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells. Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation.
  • omidubicel

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must be at least 12 years of age

          -  Applicable disease criteria

          -  Patients must have one or two partially HLA-matched CBUs

          -  Back-up stem cell source

          -  Sufficient physiological reserves

          -  Females of childbearing potential agree to use appropriate method of contraception

          -  Signed written informed consent

        Exclusion Criteria:

          -  Extensive bone marrow fibrosis

          -  Donor specific anti-HLA antibodies

          -  Pregnancy

          -  Medically unsuitable for transplant
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To assess the time from transplant to neutrophil engraftment
Time Frame:by day 42 post-transplant inclusive
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Gamida Cell ltd

Last Updated

July 28, 2020