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Safety Study of Gene Modified Donor T-cells Following TCRαβ+ Depleted Stem Cell Transplant

NCT02065869 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2023-09-29

Study results available
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Summary

This study will evaluate pediatric patients with malignant or non-malignant blood cell disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa and beta cells that comes from a partially matched family donor. The study will assess whether immune cells, called T cells, from the family donor, that are specially grown in the laboratory and given back to the patient along with the stem cell transplant can help the immune system recover faster after transplant. As a safety measure these T cells have been programmed with a self-destruct switch so that they can be destroyed if they start to react against tissues (Graft versus host disease).

Conditions

Interventions

BIOLOGICAL

BPX-501 T cells

1x10E6 cells/kg infused on Day 0

DRUG

Rimiducid

0.4mg/kg administered IV to treat GVHD

Sponsors & Collaborators

  • Bellicum Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Bellicum Pharmaceuticals · Bellicum Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2020-06-30
Completion
2021-09-07
FDA Drug
Yes

Countries

  • Italy
  • United Kingdom

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 NCT02065869 on ClinicalTrials.gov