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Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases

NCT02231710 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-03-25

Study results available
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Summary

The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.

Conditions

  • Primary Immune Deficiency Disorders
  • Hemophagocytic Lymphohistiocytosis
  • Inherited Bone Marrow Failure Syndrome
  • Hemoglobinopathies
  • Metabolic Disorders

Interventions

BIOLOGICAL

BPX-501 and Rimiducid

Single administration of BPX-501 T cells post partially-mismatched, related T cell depleted HCT followed by Rimiducid infusion on day 7

Sponsors & Collaborators

  • Bellicum Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Bellicum Pharmaceuticals Senior Director · Clinical Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-09-30
Completion
2018-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02231710 on ClinicalTrials.gov