Actively Recruiting
Clinical Trial of Autologous B7-H3 CAR T Cells in Reoccurent Platinum-resistant Ovarian Tumors
Led by Stanford University · Updated on 2026-02-09
48
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single site, open label, Phase 1 study using a 3 + 3 dose escalation design in two cohorts of adults with recurrent, platinum-resistant ovarian tumors.
CONDITIONS
Official Title
Clinical Trial of Autologous B7-H3 CAR T Cells in Reoccurent Platinum-resistant Ovarian Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of ovarian cancer including serous, endometrioid, clear cell, mucinous, mixed epithelial, or undifferentiated types
- Measurable disease with at least one lesion of specified sizes by imaging or clinical exam
- Archival tissue available or willingness to undergo biopsy for B7-H3 expression analysis
- Female aged 18 years or older
- At least one prior platinum-based chemotherapy regimen for ovarian cancer with platinum-refractory or resistant disease
- At least 3 weeks since last chemotherapy or 5 half-lives, except 3 months for checkpoint therapy
- Recovery from prior therapy toxicities to grade 1 or baseline, except certain conditions like peripheral neuropathy
- ECOG performance status of 2 or better or Karnofsky score of 60% or higher
- Life expectancy of at least 3 months as judged by investigator
- Adequate bone marrow and organ function meeting specified laboratory criteria
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Active or uncontrolled infection requiring systemic treatment within 1 week before screening, except simple UTI or bacterial pharyngitis responding to treatment
- Need for systemic corticosteroid therapy above physiologic maintenance doses (>5 mg/day prednisone or equivalent), except topical, inhaled, or ocular steroids
- Presence of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess
- Malignant tumors other than target tumor within 2 years prior to screening, except certain treated tumors with no active disease
- Serious heart conditions including NYHA class III/IV heart failure, recent myocardial infarction or coronary bypass, significant arrhythmias, or severe cardiomyopathy
- Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, lupus, or vasculitis
- Ongoing HIV, HBV, or HCV infection (history allowed if viral load undetectable)
- Untreated or active brain metastases, except stable asymptomatic previously irradiated lesions beyond specified time frames
- Known allergies to study drugs or reagents including steroids, tocilizumab, DSMO, cyclophosphamide, fludarabine
- History of significant seizure disorder excluding childhood febrile seizures
- Any other condition deemed by investigator to make participation unsafe or inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
B
Bela Shah
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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