B7-H3CART for Brain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford Cancer Institute, Palo Alto, CA
Brain+1 More
B7-H3CART - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is an open label, non-randomized, single site Phase I study to test the manufacturing feasibility and safety of locoregional (LR) administration of B7-H3CART into the central nervous system of adult subjects with recurrent IDH wild-type GBM using a standard 3+3 dose escalation design.

Eligible Conditions

  • Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 5 years

5 years
Cumulative Safety of B7-H3CART
Immunotherapy Response Assessment in Neuro-oncology (iRANO) in subjects with recurrent IDH wild-type GBM
Maximum Tolerated Dose (MTD) or Recommended phase 2 dose (RP2D)
Median overall survival (OS)
Number of successful manufacturing product (B7-H3CART) that met minimum assigned dose level range
Percentage of subjects able to receive at least three (3) doses of B7-H3CART
Time to progression (TTP)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Dose escalation
1 of 2
Dose Expansion
1 of 2
Experimental Treatment

39 Total Participants · 2 Treatment Groups

Primary Treatment: B7-H3CART · No Placebo Group · Phase 1

Dose escalation
Drug
Experimental Group · 1 Intervention: B7-H3CART · Intervention Types: Drug
Dose Expansion
Drug
Experimental Group · 1 Intervention: B7-H3CART · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Closest Location: Stanford Cancer Institute · Palo Alto, CA
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2017First Recorded Clinical Trial
0 TrialsResearching Brain
43 CompletedClinical Trials

Who is running the clinical trial?

Crystal Mackall, MDLead Sponsor
3 Previous Clinical Trials
164 Total Patients Enrolled
Reena Thomas, MD, PhDPrincipal InvestigatorStanford University

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients must have a high grade glioma with evidence of tumor recurrence/progression by MRI (RANO criteria) after standard front-line therapy.
Use of steroids must be limited to ≤ 4 mg of decadron daily.
The patient's ANC is greater than 1500/uL.
You have an absolute lymphocyte count of at least 150/uL.
You have a serum creatinine concentration of ≤ 1.

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.