ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
USWM CT, LLC
Study ID
NCT05601752
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4.

Key Dates

Start date
Jun 26, 2023
Status verified
Feb 2026
Primary completion
Aug 12, 2026
Completion
Aug 12, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous genetically modified ADP-A2M4CD8 cells
  • Experimental: Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab

Primary Outcome Measure

To evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer [ Time Frame: 3.6 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85258-
City of HopeDuarteCalifornia91010-
Augusta UniversityAugustaGeorgia30912-
Karmanos Cancer InstituteDetroitMichigan48201-
Rutgers Cancer Institute of NJNew BrunswickNew Jersey08901-
Cleveland Clinic FoundationClevelandOhio44195-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Swedish Cancer InstituteSeattleWashington98104-

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