A Phase II Study Evaluating the Safety and Efficacy of MGTA-145 in Combination With Plerixafor for the Mobilization and Transplantation of HLA-Matched Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies

Ensoma8 sites in 1 country7 target enrollmentJune 16, 2021

InterventionsMGTA-145 Plerixafor

DrugsMGTA-145 Plerixafor

Overview

Phase: Phase 2
Intervention: MGTA-145
Conditions: Related Donors Donating PBSC to a Family Member
Sponsor: Ensoma
Enrollment: 7
Locations: 8
Primary Endpoint: HSC Yield in Apheresis Product
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies. MGTA-145, the new medicine, will be given with plerixafor.

Detailed Description

This is a Phase II, open-label, multicenter, prospective study of MGTA-145 + plerixafor mobilized HLA-matched sibling and matched unrelated donor allografts for myeloablative hematopoietic stem cell transplantation (HSCT) in recipients with hematological malignancies. Donors will undergo 1 or 2 days of mobilization and apheresis.

Registry

clinicaltrials.gov

Start Date

June 16, 2021

End Date

March 14, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ensoma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Donor Inclusion Criteria:
•Donor medical suitability and eligibility will be determined following Institution or NMDP/Be The Match standards
•Age 18-65 years old at the time of signing informed consent
•8/8 (HLA- A, B, C, and DRB1) HLA-matched sibling or volunteer unrelated donor
•Fulfill Institution or NMDP/Be The Match criteria to serve as a mobilized blood cell donor
•Serum creatinine \< 1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CRCL) \> 50 mL/min using the Modification of Diet in Renal Disease Study (MDRD) equation or similar method
•Recipient Inclusion Criteria:
•At least 18 years old at the time of signing informed consent
•Has an available 8/8 (HLA- A, B, C, and DRB1) HLA-matched sibling or volunteer unrelated donor willing to donate peripheral blood stem cells (PBSC) for transplant
•Fulfill additional individual Transplant Center Criteria for transplant beyond NMDP/Be The Match criteria

Exclusion Criteria

•Donor Exclusion Criteria:
•Donor unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
•Donor already enrolled on another investigational agent study
•Pregnant or breastfeeding females, sexually active female and male donors not willing or able to use adequate contraception, or males who do not agree to refrain from donating sperm, from the time of consent through 3 months after treatment with MGTA-145 + plerixafor
•Recipient Exclusion Criteria:
•Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
•Subject whose donor does not meet the eligibility criteria and is a screen fail
•Subjects with a prior allogeneic transplant
•Subjects with active, uncontrolled infection at the time of the transplant preparative regimen
•Pregnant or breastfeeding females, sexually active female or male subjects not willing or able to use adequate contraception, or males who do not agree to refrain from donating sperm, from the time of consent through 3 months after PBSC infusion