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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: Recruiting Phase 1 study of Diffuse Midline Glioma, H3 K27M-Mutant, sponsored by University of California, San Francisco.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To determine the safety and tolerability of a single intravenous (IV) infusion of KIND T cells in HLA A\*0201+ participants with H3.3K27M+ diffuse midline gliomas
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-07-20 |
| Est. Completion | 2029-08-31 |
| Phase | Phase 1 |
What NCT05478837 shows while recruiting
NCT05478837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 232-participant average among 11 other Diffuse Midline Glioma, H3 K27M-Mutant trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05478837's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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