A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04024761
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CIML NK — BIOLOGICAL
    CIML NK cells have enhanced ability to recognize and kill leukemia targets
  • Fludarabine — DRUG
    Fludarabine is a chemotherapy agent
  • Cyclophosphamide — DRUG
    Cyclophosphamide (CP), also known as cytophosphane among other names, is a chemotherapy agent

Study Details

This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.

Key Dates

Start date
Aug 31, 2019
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CIML NK
    * CIML NK cells will be administered intravenously on day 0. * Fludarabine will be administered as IV infusion once daily for 3 doses beginning on day -5. * Cyclophosphamide will be administered as IV infusion on days -5 and -4.

Primary Outcome Measure

Safety [ Time Frame: 6 Weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Susanne Baumeister, MD
[email protected]
(617) 632-4687
Susanne Baumeister, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Roman Shapiro, MD
[email protected]
617) 632-3470
Roman Shapiro, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Boston Children's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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