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NCT05478837 · ClinicalTrials.gov registry record · Phase 1

Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With H3.3K27M-Mutated Glioma

A Phase 1 study of Diffuse Midline Glioma, H3 K27M-Mutant, sponsored by University of California, San Francisco.

Recruiting
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT05478837 is a Phase 1 study of Diffuse Midline Glioma, H3 K27M-Mutant that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 12 participants, below the 232-participant average among 11 other Diffuse Midline Glioma, H3 K27M-Mutant trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05478837, a Phase 1 study of Diffuse Midline Glioma, H3 K27M-Mutant, is actively recruiting participants, sponsored by University of California, San Francisco.

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

Study Summary

This phase I, first-in-human trial tests the safety, side effects, and best dose of genetically modified cells called KIND T cells after lymphodepletion (a short dose of chemotherapy) in treating patients who are HLA-A\*0201-positive and have H3.3K27M-mutated diffuse midline glioma. KIND T cells are a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory into KIND T cells so they will recognize certain markers found in tumor cells. Drugs such as cyclophosphamide and fludarabine are chemotherapy drugs used to decrease the number of T cells in the body to make room for KIND T cells. Giving KIND T cells after cyclophosphamide and fludarabine may be more useful against cancer compared to the usual treatment for patients with H3.3K27M-mutated diffuse midline glioma (DMG).

Conditions Studied

Diffuse Midline Glioma, H3 K27M-Mutant

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL Autologous Anti-H3.3K27M TCR-expressing T-cells

Study Locations (1)

California

  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2023-07-20
Est. Completion 2029-08-31
Phase Phase 1

Sponsor

University of California, San Francisco

1,713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05478837

The ClinicalTrials.gov registry entry for NCT05478837 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 232-participant average among 11 other Diffuse Midline Glioma, H3 K27M-Mutant trials with a reported enrollment target (95% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diffuse Midline Glioma, H3 K27M-Mutant appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.

NCT05478837 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05478837 about?

NCT05478837 is a clinical study titled "Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With H3.3K27M-Mutated Glioma". This phase I, first-in-human trial tests the safety, side effects, and best dose of genetically modified cells called KIND T cells after lymphodepletion (a short dose of chemotherapy) in treating patients who are HLA-A\*0201-positive and have H3.3K27M-mutated diffuse midline glioma. KIND T cells are...

What is the current status of trial NCT05478837?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-07-20. Estimated completion is 2029-08-31.

What conditions does trial NCT05478837 study?

This clinical trial studies the following conditions: Diffuse Midline Glioma, H3 K27M-Mutant.

What interventions are being tested in trial NCT05478837?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Autologous Anti-H3.3K27M TCR-expressing T-cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT05478837?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05478837 being conducted?

This trial has 1 study location across California. 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.