Treatment (KIND T cells, cyclophosphamide, fludarabine) for Diffuse Midline Glioma, H3 K27M-Mutant

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Diffuse Midline Glioma, H3 K27M-Mutant+1 More
Fludarabine - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions

  • Diffuse Midline Glioma, H3 K27M-Mutant

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 24 months

Up to 12 months
Duration of KIND T cells in-vivo persistence
Percentage of participants who receive KIND T cells
Up to 24 months
Number of participants with treatment-emergent adverse events
Day 28
Maximum tolerated dose (MTD)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (KIND T cells, cyclophosphamide, fludarabine)
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (KIND T cells, cyclophosphamide, fludarabine) · No Placebo Group · Phase 1

Treatment (KIND T cells, cyclophosphamide, fludarabine)Experimental Group · 3 Interventions: Fludarabine, Cyclophosphamide, Autologous Anti-H3.3K27M TCR-expressing T-cells · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 2
~1240
Cyclophosphamide
1995
Completed Phase 3
~4020

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Trial Background

Sabine Mueller,, MD PhD
Principal Investigator
University of California, San Francisco
Closest Location: University of California, San Francisco · San Francisco, CA
Photo of San Francisco  1Photo of San Francisco  2Photo of San Francisco  3
2008First Recorded Clinical Trial
3 TrialsResearching Diffuse Midline Glioma, H3 K27M-Mutant
688 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and of childbearing potential.
You must have a central nervous system (CNS) reservoir such as an Ommaya catheter in place.
Participants must be positive for HLA-A*0201.
You must consent for tumor tissue (fresh or archival) for biomarker analysis.
You are female and of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.