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| Name | Class |
|---|---|
| Anixa Biosciences, Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of FSHCER T Cells | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of response is measured from the time measurement criteria are met for immune complete response or immune partial response (whichever is first recorded) until the first date that progressive disease (immune related progressive disease -irPD) is objectively documented (taking as reference for PD the smallest measurements recorded [nadir] since the treatment started). |
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Inclusion Criteria:
Exclusion Criteria:
Clinically significant heart disease (New York Heart Association class 3 or 4) or symptomatic congestive heart failure.
Myocardial infarction <6 months before enrollment. History of clinically significant ventricular arrhythmia or unexplained syncope that is not believed to be vasovagal in nature or due to dehydration.
History of severe non-ischemic cardiomyopathy with ejection fraction <20%. Findings on baseline ECG or ECHO that, in the opinion of the patient's treating physician or investigator, would require medical intervention before anticancer therapy
Serious uncontrolled medical illness or disorder that in the opinion of the treating physician would make the patient ineligible for the study.
Active uncontrolled infection (with the exception of uncomplicated urinary tract infection).
Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess. Abdominal surgery (for reasons other than IP port placement).
female participants only
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley K O'Neil | Contact | 813-745-5240 | Ashley.ONeil@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert M Wenham, MD, MS, FACOG, FACS | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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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. |
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| 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). |
|
| Up to 15 years |
| Duration of Stable Disease | Stable Disease is measured from the start of the treatment until the criteria for confirmed progressive disease are met. | Up to 15 years |
| Overall Survival | Overall survival defined as the time from initial date of treatment to date of death. | Up to 15 years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |