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NCT03378102 · ClinicalTrials.gov registry record · Early Phase 1

Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation

A Early Phase 1 study of Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Mari Dallas.

Recruiting
Registry status
Early Phase 1
Development phase
20
Enrollment target
1
Study location

NCT03378102: Recruiting Early Phase 1 study of Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Mari Dallas.

NCT03378102 is a Early Phase 1 study of Allogeneic Hematopoietic Stem Cell Transplantation that is actively recruiting participants, run by Mari Dallas. The registered enrollment target is 20 participants, below the 113-participant average among 3 other Allogeneic Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03378102, a Early Phase 1 study of Allogeneic Hematopoietic Stem Cell Transplantation, is actively recruiting participants, sponsored by Mari Dallas.

RECRUITING
Registry status
Early Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy. Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into the patient, to try to give the immune system the ability to fight the infection. Adoptive T cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).

Primary Outcome

This is a measure of feasibility: Severe adverse events are related to the infusion of virus-specific, antigen selected T cells, Grade ≥ 3 acute graft versus host disease,• Death within 30 days of the infusion of the virus-specific, antigen selected T cells that is considered by the investigators to be probably or possibly related to the T cell infusion

Interventions

  • BIOLOGICAL IFN-gamma-secreting HAdV antigen specific T cells

Study Locations (1)

Ohio

  • University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-01-04
Est. Completion 2028-12
Phase Early Phase 1
Mari Dallas

2 total trials

What NCT03378102 shows while recruiting

NCT03378102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 113-participant average among 3 other Allogeneic Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (82% lower).

The record links to 1 condition, with Allogeneic Hematopoietic Stem Cell Transplantation appearing as the primary indexed condition, and to 1 intervention - of which IFN-gamma-secreting HAdV antigen specific T cells is the first listed.

NCT03378102 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT03378102 about?

NCT03378102 is a clinical study titled "Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation". The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxic...

What is the current status of trial NCT03378102?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2019-01-04. Estimated completion is 2028-12.

What conditions does trial NCT03378102 study?

This clinical trial studies the following conditions: Allogeneic Hematopoietic Stem Cell Transplantation.

What interventions are being tested in trial NCT03378102?

The interventions under investigation include: IFN-gamma-secreting HAdV antigen specific T cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT03378102?

This trial is sponsored by Mari Dallas, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03378102 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03378102, the US trial registry maintained by the National Library of Medicine. NCT03378102 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.