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Phase 1 B7-H3 CAR T-cell Therapy for Recurrent Ovarian Cancer

This study is testing a new cell therapy called B7-H3CART for women with ovarian cancer that has come back and is resistant to platinum-based chemotherapy. Researchers want to see if B7-H3CART can be safely manufactured and what the highest safe dose is. You may be eligible if you are an adult woman with a confirmed diagnosis of certain types of ovarian cancer that has returned and is platinum-resistant. The study is currently unclear about its recruitment status and plans to enroll 48 participants.

Study design
This is a Phase 1, single-site study with an open-label design, meaning both you and your doctors will know which treatment you are receiving. It uses a 3+3 dose escalation design in two groups of adults.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the maximum tolerated dose 28 days after B7-H3CART infusion, and the feasibility of manufacturing B7-H3CART for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06646627

Clinical Trial of Autologous B7-H3 CAR T Cells in Reoccurent Platinum-resistant Ovarian Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Stanford University
~48 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:B7-H3CART

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of B7-H3CART Manufacturing
Measured over 2 years
+1 more outcome measured

Conditions

Ovarian Cancer

Explore related trials

Malignant Ovarian Neoplasm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Oliver Dorigo, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Bela Shah
[email protected]
650-723-0594
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hgb ≥ 10 g/dL
ANC ≥ 1500/uL
Platelet count ≥ 100,000/uL
Absolute lymphocyte count ≥150/uL
Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min
Serum ALT and AST ≤ 5x ULN (Grade 2)
Total bilirubin ≤ 1.5x ULN (subjects with Gilbert's syndrome allowed if direct bilirubin within normal limits)
PT or PTT ≤ 1.25 X ULN (not receiving therapeutic anticoagulation)
Cardiac ejection fraction ≥ 45%
No evidence of physiologically significant pericardial effusion
No clinically significant ECG findings
Baseline oxygen saturation \> 92% on room air 9. Pregnancy: Females of childbearing potential (defined as women ≤50 years of age, or \>50 years of age with a history of amenorrhea for ≤12 months prior to study entry) must have a negative blood or urine pregnancy test.

Exclusion

1\. Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
Clinically significant ventricular arrhythmia, or a history of unexplained syncope (except those caused by vasovagal or dehydration);
History of severe nonischemic cardiomyopathy. 6. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.

What this trial measures

  • Feasibility of B7-H3CART Manufacturing2 years

    Feasibility is defined by the frequency of successful manufacturing runs of B7-H3CART that meet the established Investigational New Drug (IND) release criteria and the targeted dose level.

  • Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)28 days after B7-H3CART infusion

    MTD and/or RP2D defined in each arm (IP and IV) based on the number of events meeting definition of dose limiting toxicity (DLT) measured 28 days after infusion, tested in at least 6 evaluable participants in each arm.