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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06646627
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • B7-H3CART — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 11, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Intraperitoneal (IP) Administration
    At the time of enrollment, based on imaging studies, clinical history and physical exams, the principal investigator will make a preliminary decision regarding Arm Assignment. Participants with ovarian cancer confined to the peritoneum will undergo laparoscopic placement of an intraperitoneal catheter (PowerPort™ device and catheter) for cell infusion. When feasible, a Tenckhoff catheter for research sample collection of ascites, will also be placed. If laparoscopic placement is not possible, the PowerPort catheter may be inserted in interventional radiology. If adhesions within the peritoneum would preclude effective distribution of CAR cells throughout the peritoneum, the participant may be placed in Arm B.
  • Experimental: Intravenous (IV) Administration
    At the time of enrollment, based on imaging studies, clinical history and physical exams, the principal investigator will make a preliminary decision regarding Arm Assignment. Arm B will consist of participants with disease outside the peritoneum and with participants who either cannot undergo IP catheter insertion or who, in the judgement of the principal investigator do not have an intraperitoneal environment that would allow for adequate product distribution. Participants in Arm B will have a Tenckhoff catheter inserted in Interventional Radiology at least 7 days before the start of conditioning lymphodepletion.

Primary Outcome Measure

Feasibility of B7-H3CART Manufacturing [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Bela Shah
[email protected]
650-723-0594
Oliver Dorigo, MD,Phd (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Stanford University· Palo Alto, CA

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