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NCT07257419 · ClinicalTrials.gov registry record · Phase 1

CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma

A Phase 1 study of Hematologic Malignancy and Hematopoietic Cell Transplantation, sponsored by St. Jude Children's Research Hospital.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT07257419 is a Phase 1 study of Hematologic Malignancy and Hematopoietic Cell Transplantation that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 60 participants, below the 227-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07257419, a Phase 1 study of Hematologic Malignancy and Hematopoietic Cell Transplantation, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.

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

Study Summary

The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL. Primary Objective: \- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. Secondary Objectives: * To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS). * To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.

Conditions Studied

Hematologic Malignancy Hematopoietic Cell Transplantation Relapsed Pediatric ALL

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Mesna
  • DRUG Thiotepa
  • DRUG Anti-Thymocyte Globulin (Rabbit)

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2026-03-03
Est. Completion 2035-12
Phase Phase 1

Sponsor

St. Jude Children's Research Hospital

410 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07257419

The ClinicalTrials.gov registry entry for NCT07257419 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 227-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (74% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Hematologic Malignancy appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT07257419 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT07257419 about?

NCT07257419 is a clinical study titled "CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma". The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL. Primary Objective: \- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+...

What is the current status of trial NCT07257419?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-03-03. Estimated completion is 2035-12.

What conditions does trial NCT07257419 study?

This clinical trial studies the following conditions: Hematologic Malignancy, Hematopoietic Cell Transplantation, Relapsed Pediatric ALL.

What interventions are being tested in trial NCT07257419?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), Thiotepa (DRUG), Anti-Thymocyte Globulin (Rabbit) (DRUG).

Who is sponsoring clinical trial NCT07257419?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07257419 being conducted?

This trial has 1 study location across Tennessee. 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.