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NCT06777979 · ClinicalTrials.gov registry record · Phase 1

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

A Phase 1 study of Acute Lymphoblastic Leukemia and Recurrent Acute Lymphoblastic Leukemia, sponsored by St. Jude Children's Research Hospital.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT06777979 is a Phase 1 study of Acute Lymphoblastic Leukemia and Recurrent Acute Lymphoblastic Leukemia that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 30 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06777979, a Phase 1 study of Acute Lymphoblastic Leukemia and Recurrent Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.

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

Study Summary

This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.

Conditions Studied

Acute Lymphoblastic Leukemia Recurrent Acute Lymphoblastic Leukemia Recurrent B Acute Lymphoblastic Leukemia

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Mesna
  • DEVICE CD19-CD22 CAR T cell infusion

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-04-28
Est. Completion 2031-01
Phase Phase 1

Sponsor

St. Jude Children's Research Hospital

410 total trials

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What the Registry Record Tells You About NCT06777979

The ClinicalTrials.gov registry entry for NCT06777979 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (92% 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 Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT06777979 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT06777979 about?

NCT06777979 is a clinical study titled "CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia". This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-p...

What is the current status of trial NCT06777979?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-04-28. Estimated completion is 2031-01.

What conditions does trial NCT06777979 study?

This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT06777979?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), CD19-CD22 CAR T cell infusion (DEVICE).

Who is sponsoring clinical trial NCT06777979?

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

Where is trial NCT06777979 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.