A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06469281
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer. This study has two (2) major parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51. Information collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.

Key Dates

Start date
Aug 6, 2024
Status verified
Jan 2026
Primary completion
May 27, 2030
Completion
May 27, 2030

Study Design

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

Arms

  • Experimental: Dose Escalation
    27T51 monotherapy
  • Experimental: Dose Expansion - Arm A
    27T51 monotherapy
  • Experimental: Dose Expansion - Arm B
    27T51+Cemiplimab
  • Experimental: Dose Expansion - Arm C
    27T51+Cemiplimab+Bevacizumab

Primary Outcome Measure

Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 18 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Oladapo Yeku, MD, FACP
617-643-9354
John Theurer Cancer Center Hackensack University Medical CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Roswell Park Cancer InstituteBuffaloNew York14203
Laura Ryan
[email protected]
716-845-3057
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
[email protected]
878-261-6063
LDS HospitalSalt Lake CityUtah84143
Joshua Kunz
[email protected]
801-408-4724

Find similar trials in Boston, MA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Massachusetts General Hospital· Boston, MAJohn Theurer Cancer Center Hackensack University Medical Center· Hackensack, NJRoswell Park Cancer Institute· Buffalo, NYUPMC Hillman Cancer Center· Pittsburgh, PALDS Hospital· Salt Lake City, UT

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