RecruitingPhase 1NCT06646627

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

Phase I Clinical Trial of Autologous B7-H3 Chimeric Receptor (CAR) T Cells in Adults With Recurrent, Platinum Resistant Ovarian Tumors


Sponsor

Stanford University

Enrollment

48 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental CAR-T cell therapy — where a patient's own immune cells are reprogrammed to target a protein called B7-H3 — for women with ovarian cancer that has come back and is no longer responding to platinum-based chemotherapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with ovarian cancer (most types of epithelial ovarian cancer are eligible) - You have received at least one platinum-based chemotherapy regimen and your cancer is now platinum-resistant or platinum-refractory (meaning it came back or did not respond) - You have at least one measurable tumor - You are in reasonably good physical condition (ECOG score 0–2) - You have a life expectancy of at least 3 months - You are willing to provide a tumor tissue sample **You may NOT be eligible if...** - You have pure sarcoma, stromal, or germ cell ovarian tumor - You are in very poor general health - You have significant unresolved toxicity from prior treatments - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGB7-H3CART

Dose Levels: Dose Level -1 Dose Level 1 Dose Level 2 Dose Level 3 Arm A IP(± 20%) (flat dose) Dose Level -1: 1 x 107 B7-H3CART Dose Level 1: 5 x 107 B7-H3CART Dose Level 2: 15 x 107 B7-H3CART Dose Level 3: 5 x 108 B7-H3CART Arm B: IV (± 20%) (weight based) Dose Level -1: 3 x 105 transduced cells/kg Dose Level 1: 1 x 106 transduced cells/kg Dose Level 2: 3 x 106 transduced cells/kg Dose Level 3: 10 x 106 transduced cells/kg


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT06646627


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