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NCT06839456 · ClinicalTrials.gov registry record · Phase 1

Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT

A Phase 1 study of Leukemia and Relapsed Non-Hodgkin Lymphoma, sponsored by Children's Hospital of Philadelphia.

Recruiting
Registry status
Phase 1
Development phase
100
Enrollment target
1
Study location

NCT06839456 is a Phase 1 study of Leukemia and Relapsed Non-Hodgkin Lymphoma that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 100 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06839456, a Phase 1 study of Leukemia and Relapsed Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.

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

Study Summary

The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab/CD19 depleted PSCT.

Interventions

  • DEVICE Phase 1 Dose Level 1
  • DEVICE Phase 1 Dose Level 2
  • DEVICE Phase 1 Dose Level 3
  • DEVICE Phase 2 Maximum Tolerated Dose determined in Phase 1
  • DEVICE Phase 2 Established Dose from prior study, NCT03810196

Study Locations (1)

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2025-03-21
Est. Completion 2032-03
Phase Phase 1

Sponsor

Children's Hospital of Philadelphia

431 total trials

What the Registry Record Tells You About NCT06839456

The ClinicalTrials.gov registry entry for NCT06839456 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (79% lower). The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Phase 1 Dose Level 1 is the first listed.

NCT06839456 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06839456 about?

NCT06839456 is a clinical study titled "Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT". The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte d...

What is the current status of trial NCT06839456?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-03-21. Estimated completion is 2032-03.

What conditions does trial NCT06839456 study?

This clinical trial studies the following conditions: Leukemia, Relapsed Non-Hodgkin Lymphoma, MDS (Myelodysplastic Syndrome), Immunodeficiency, High Risk Acute Myeloid Leukemia.

What interventions are being tested in trial NCT06839456?

The interventions under investigation include: Phase 1 Dose Level 1 (DEVICE), Phase 1 Dose Level 2 (DEVICE), Phase 1 Dose Level 3 (DEVICE), Phase 2 Maximum Tolerated Dose determined in Phase 1 (DEVICE), Phase 2 Established Dose from prior study, NCT03810196 (DEVICE).

Who is sponsoring clinical trial NCT06839456?

This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06839456 being conducted?

This trial has 1 study location across Pennsylvania. 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

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