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ACTIVE NOT RECRUITING
NCT05478837
PHASE1

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

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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).

Official title: PNOC018 A Phase 1 Clinical Trial of Autologous T Cells Expressing a TCR Specific for H3.3K27M With Inhibition of Endogenous TCR (KIND T Cells) in HLA-A*0201-positive Participants With H3.3K27M-positive Diffuse Midline Gliomas

Key Details

Gender

All

Age Range

2 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-07-20

Completion Date

2029-08-31

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

Autologous Anti-H3.3K27M TCR-expressing T-cells

Given IV

Locations (1)

University of California, San Francisco

San Francisco, California, United States