Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05316129
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Follicle Stimulating Hormone Receptor T Cells — DRUG
    Participants will receive an infusion of autologous t cells genetically modified ex vivo to express the FSHR-specific 4-1BB/CD3ζ CER.

Study Details

The purpose of this first in human study is to evaluate the safety of treatment with autologous T cells genetically modified to express a CER (chimeric endocrine receptor) targeting the FSHR (follicle-stimulating hormone receptor) (FSHCER T cells), with or without conditioning chemotherapy, in participants with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.

Key Dates

Start date
Apr 28, 2022
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
May 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intraperitoneal treatment- Dose Level 1
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10\^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
  • Experimental: Intravenous treatment - Dose Level 1
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10\^5 by Intravenous (IV).
  • Experimental: Intraperitoneal treatment- Dose Level 2
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10\^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
  • Experimental: Intravenous treatment - Dose Level 2
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10\^5 by Intravenous (IV).
  • Experimental: Intraperitoneal treatment- Dose Level 3
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10\^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
  • Experimental: Intravenous treatment - Dose Level 3
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10\^6 by Intravenous (IV).
  • Experimental: Intraperitoneal treatment- Dose Level 4
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10\^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
  • Experimental: Intravenous treatment - Dose Level 4
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10\^6 by Intravenous (IV).
  • Experimental: Intraperitoneal treatment- Dose Level 5
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10\^7. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
  • Experimental: Intravenous treatment - Dose Level 5
    Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10\^7 by Intravenous (IV).

Primary Outcome Measure

Maximum Tolerated Dose of FSHCER T Cells [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Ashley K O'Neil
[email protected]
813-745-5240
Kimberly Sprenger
[email protected]
813-745-0330
Robert M Wenham, MD, MS, FACOG, FACS (PRINCIPAL_INVESTIGATOR)
Daniel Abate-Daga, PhD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Moffitt Cancer Center· Tampa, FL

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