NCT06646627

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	B7-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

Timeline

• Start date: 2024-11-11
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-10-17
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study