Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05316129 | Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer | PHASE1 | RECRUITING | 10 | — | — | Apr 28, 2022 | May 1, 2029 | Dec 5, 2025 | 1 | United States |
Participants will receive escalating doses of FSHCER T Cells to determine the Maximum Tolerated Dose (MTD). MTD is defined as the the highest dose of t cells that does not cause unacceptable side effects.
| Arm | Type | Description |
|---|---|---|
| Intraperitoneal treatment- Dose Level 1 | EXPERIMENTAL | 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. |
| Intravenous treatment - Dose Level 1 | EXPERIMENTAL | 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). |
| Intraperitoneal treatment- Dose Level 2 | EXPERIMENTAL | 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. |
| Intravenous treatment - Dose Level 2 | EXPERIMENTAL | 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). |
| Intraperitoneal treatment- Dose Level 3 | EXPERIMENTAL | 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. |
| Intravenous treatment - Dose Level 3 | EXPERIMENTAL | 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). |
| Intraperitoneal treatment- Dose Level 4 | EXPERIMENTAL | 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. |
| Intravenous treatment - Dose Level 4 | EXPERIMENTAL | 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). |
| Intraperitoneal treatment- Dose Level 5 | EXPERIMENTAL | 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. |
| Intravenous treatment - Dose Level 5 | EXPERIMENTAL | 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). |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Aged 18 years or older and able to provide informed consent. * Pathologically confirmed diagnosis of invasive (Grades 1-3) epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma (EOC), which are serous, endometrioid, clear cell, mucinous, mixed epith...