Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06138587
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Cytokine Induced Memory-like Natural Killer Cells — BIOLOGICAL
    Allogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol.
  • Interleukin-2 — BIOLOGICAL
    Recombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous injection per protocol.

Study Details

The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant. Names of the study therapies involved in this study are: * CIML NK cells intravenous infusion (cellular therapy) * Subcutaneous Interleukin-2 (recombinant, human glycoprotein)

Key Dates

Start date
Jan 24, 2024
Status verified
Dec 2025
Primary completion
Feb 28, 2027
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Phase 1/1b: CIML NK Cells + Interleukin-2
    5 eligible participants will be enrolled to determine the maximum tolerated dose (MTD) of CIML NK at starting dose level 0. * Screening and baseline visit with assessments and bone marrow aspirate and biopsy. * Day 0: Standard-of-care conditioning chemotherapy and stem cell infusion. * Day 7: Predetermined dose of CIML NK cells 1x daily. * Days 7, 9, 11, 13, 15: Predetermined dose of Interleukin-2 1x daily every other day (5 doses total). * Dose limiting toxicity period for 6 weeks after infusion of CIML NK cells If 0 or 1 dose limiting toxicity is observed at the dose level, then this dose will be the MTD and study will proceed to Phase 1b. De-escalation to dose level -1 per protocol if ≥2 DLTs occur with dose Level 0. In phase Ib, 10 additional participants will be enrolled at the maximum tolerated dose.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [Phase 1] [ Time Frame: 6 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Roman Shapiro, MD
[email protected]
617-632-3470
Roman Shapiro, 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
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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