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Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation

NCT02782546 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-24

No results posted yet for this study

Summary

This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia free survival to 30% from \<10% expected with the use of reduced intensity haplo-HCT in this extremely high-risk patient cohort (based on the institutional experience using non-myeloablative / reduced intensity conditioning in a similar patient cohort).

A formal safety evaluation will be done after every 6th patient enrolled and the trial will be stopped if noted to have unusually higher engraftment failure (acute GVHD rates (\>60% any grades or \>30% grade III/IV or ≥ 50% severe cGVHD) or engraftment failure rates (≥15%).

Conditions

Interventions

DRUG

ALT-803

-Start approximately 4 hours after CIML NK cell infusion

PROCEDURE

Leukapheresis

-Day +6

PROCEDURE

CIML NK cell infusion

-Day +7

DRUG

Mycophenolate mofetil

-GVHD prophylaxis

DRUG

G-CSF

-Continue until neutrophil engraftment as per institutional guidelines

PROCEDURE

Graft cell infusion

-Day 0

DRUG

Tacrolimus

-GVHD prophylaxis

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • The V Foundation for Cancer Research

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • ImmunityBio, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Amanda Cashen, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2025-10-27
Completion
2028-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02782546 on ClinicalTrials.gov