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

NCT06646627 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-02-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Oliver Dorigo, MD, PhD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646627 on ClinicalTrials.gov