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NCT04897321 · ClinicalTrials.gov registry record · Phase 1

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

A Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by St. Jude Children's Research Hospital.

Recruiting
Registry status
Phase 1
Development phase
32
Enrollment target
1
Study location

NCT04897321 is a Phase 1 study of Neuroblastoma and Osteosarcoma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 32 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04897321, a Phase 1 study of Neuroblastoma and Osteosarcoma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.

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

Study Summary

3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells

Conditions Studied

Neuroblastoma Osteosarcoma Rhabdomyosarcoma Ewing Sarcoma Wilms Tumor Pediatric Solid Tumor Desmoplastic Small Round Cell Tumor Rhabdoid Tumor Germ Cell Cancer Adrenocortical Cancer

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG MESNA
  • DRUG B7-H3 CAR T cells

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2022-07-06
Est. Completion 2027-03-01
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 NCT04897321

The ClinicalTrials.gov registry entry for NCT04897321 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (87% 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 10 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT04897321 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT04897321 about?

NCT04897321 is a clinical study titled "B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)". 3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate ...

What is the current status of trial NCT04897321?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-07-06. Estimated completion is 2027-03-01.

What conditions does trial NCT04897321 study?

This clinical trial studies the following conditions: Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma, Ewing Sarcoma, Wilms Tumor.

What interventions are being tested in trial NCT04897321?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), MESNA (DRUG), B7-H3 CAR T cells (DRUG).

Who is sponsoring clinical trial NCT04897321?

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

Where is trial NCT04897321 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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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.