Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies

NCT02743351 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-02-08

Study results available
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Summary

This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.

Conditions

Interventions

BIOLOGICAL

ProTmune

Ex-vivo, programmed mobilized peripheral blood (mPB) cells

BIOLOGICAL

Control Arm

Untreated mobilized peripheral blood (mPB) cells

Sponsors & Collaborators

Principal Investigators

  • Sarah Cooley, MD · Fate Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2020-12-04
Completion
2021-11-05

Countries

  • United States

Study Locations

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Entities

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 NCT02743351 on ClinicalTrials.gov