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NCT03301168 · ClinicalTrials.gov registry record · Phase 1

Study of Gene Modified Donor T-cells Following TCR Alpha Beta Positive Depleted Stem Cell Transplant

A Phase 1 study of Myelodysplastic Syndromes and Acute Lymphoblastic Leukemia, sponsored by Bellicum Pharmaceuticals.

Active
Registry status
Phase 1
Development phase
120
Enrollment target
10
Study locations

NCT03301168 is a Phase 1 study of Myelodysplastic Syndromes and Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Bellicum Pharmaceuticals. The registered enrollment target is 120 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (58% lower). The trial reports 10 study locations across 8 states.

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The verdict

NCT03301168, a Phase 1 study of Myelodysplastic Syndromes and Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Bellicum Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
120 participants
Enrollment target
10
Study locations

Study 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 Studied

Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Lymphoma, Non-Hodgkin Cytopenia Primary Immune Deficiency Disorder Anemia, Aplastic Osteopetrosis Leukemia, Acute Myeloid (AML), Child Hemoglobinopathy in Children

Interventions

  • DRUG Rimiducid
  • BIOLOGICAL BPX-501 T cells

Study Locations (10)

California

  • Children's Hospital Los Angeles - Los Angeles
  • Stanford University - Division of Pediatric Stem Cell Transplant & Regenerative Medicine - Palo Alto

Texas

  • University of Texas Southwestern-Children's Medical Center - Dallas
  • Baylor College of Medicine/ Texas Children's Hospital - Houston

District of Columbia

  • Children's National Medical Center - Washington D.C.

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Massachusetts

  • Dana-Farber Boston Children's Cancer and Blood Disorders Center - Boston

New York

  • Children's Hospital at Montefiore - The Bronx

Oregon

  • Oregon Health Sciences University - Doernbecher Children's Hospital - Portland

Washington

  • Fred Hutchinson Cancer Research Center - Seattle

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2014-04
Est. Completion 2034-05
Phase Phase 1

Sponsor

Bellicum Pharmaceuticals

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03301168

The ClinicalTrials.gov registry entry for NCT03301168 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (58% lower). The listed sponsor is Bellicum Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Rimiducid is the first listed.

NCT03301168 reports 10 study locations spanning 8 distinct geographic areas - top geographies include California, Texas, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT03301168 about?

NCT03301168 is a clinical study titled "Study of Gene Modified Donor T-cells Following TCR Alpha Beta Positive Depleted Stem Cell Transplant". 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 ce...

What is the current status of trial NCT03301168?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2014-04. Estimated completion is 2034-05.

What conditions does trial NCT03301168 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia, Lymphoma, Non-Hodgkin, Cytopenia, Primary Immune Deficiency Disorder.

What interventions are being tested in trial NCT03301168?

The interventions under investigation include: Rimiducid (DRUG), BPX-501 T cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT03301168?

This trial is sponsored by Bellicum Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03301168 being conducted?

This trial has 10 study locations across California, District of Columbia, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.