← Back to Search

CAR T-cell Therapy

Genetically Modified T-Cells for Brain Cancer (PNOC018 Trial)

Phase 1
Recruiting
Led By Sabine Mueller, MD, PhD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of KIND T cells, which are modified immune cells, in patients with a specific type of brain tumor. The treatment involves chemotherapy to prepare for the new T cells, which are designed to better attack the cancer.

Who is the study for?
This trial is for HLA-A*0201-positive patients aged 3-21 with a specific brain tumor (H3.3K27M-mutated diffuse midline glioma) who've finished standard radiation therapy. They must not be pregnant, agree to use contraception, and have no immune disorders like HIV or hepatitis B/C. No prior treatments for the tumor are allowed.
What is being tested?
The trial tests genetically modified KIND T cells after chemotherapy drugs cyclophosphamide and fludarabine in young patients with a certain type of brain cancer. It aims to find the safest dose and see how well these engineered T cells can target and fight the tumor.
What are the potential side effects?
Potential side effects include reactions from the infusion of modified T cells, low blood cell counts due to chemotherapy, increased risk of infections, nausea, fatigue, and possible organ inflammation as an immune response.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD)
Number of participants with treatment-emergent adverse events
Secondary study objectives
Duration of KIND T cells in-vivo persistence
Percentage of participants who receive KIND T cells

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (KIND T cells, cyclophosphamide, fludarabine)Experimental Treatment3 Interventions
Patients receive fludarabine IV on days -4, -3, and -2 and cyclophosphamide IV on day -2 in the absence of disease progression or unacceptable toxicity for the conditioning regimen. Patients also receive KIND T cells IV at dose level 1 (2 x 106 dextramer®+ CD8+ cells/kg) on day 0. If no DLTs are reported, newly enrolling participants may receive dose level 2 of KIND T cells on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Diffuse Midline Glioma (DMG) include radiation therapy and emerging immunotherapies like genetically modified T cells. Radiation therapy works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and grow. Genetically modified T cells, such as KIND T cells, are engineered to recognize and attack tumor-specific markers, enhancing the immune system's ability to target and destroy cancer cells. This approach is particularly significant for DMG patients because it offers a targeted treatment option that can potentially overcome the tumor's resistance to conventional therapies, providing a new avenue for managing this aggressive cancer.

Find a Location

Who is running the clinical trial?

Alliance for Cancer Gene TherapyUNKNOWN
2 Previous Clinical Trials
55 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,591 Previous Clinical Trials
14,901,541 Total Patients Enrolled
The V FoundationOTHER
7 Previous Clinical Trials
239 Total Patients Enrolled

Media Library

Autologous Anti-H3.3K27M TCR-expressing T-cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05478837 — Phase 1
Diffuse Midline Glioma Research Study Groups: Treatment (KIND T cells, cyclophosphamide, fludarabine)
Diffuse Midline Glioma Clinical Trial 2023: Autologous Anti-H3.3K27M TCR-expressing T-cells Highlights & Side Effects. Trial Name: NCT05478837 — Phase 1
Autologous Anti-H3.3K27M TCR-expressing T-cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05478837 — Phase 1
~8 spots leftby Aug 2029