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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.
Former Sponsor 2seventy bio
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | 27T51 monotherapy |
|
| Dose Expansion - Arm A | Experimental | 27T51 monotherapy |
|
| Dose Expansion - Arm B | Experimental | 27T51+Cemiplimab |
|
| Dose Expansion - Arm C | Experimental | 27T51+Cemiplimab+Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 27T51 | Other | Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | Part 1a | Up to 18 months |
| Incidence of adverse events of special interest (AESIs) | Part 1a | Up to 18 months |
| Incidence of adverse events of dose limiting toxicities (DLTs) | Part 1a | Up to 18 months |
| Manufacturing feasibility of 27T51 | Phase 1a/1b Determination of the feasibility of manufacturing 27T51 is measured by the percent of leukapheresis products collected that are able to be manufactured and released for infusion. | Up to 3 years |
| Overall response rate (ORR) as assessed by the investigator | Phase 1b | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR as assessed by the investigator | Phase 1a | Up to 48 months |
| Duration of response (DoR) | Phase 1a/1b | Up to 48 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Cemiplimab | Drug | IV infusion |
|
|
| Bevacizumab | Drug | IV Infusion |
|
|
| Disease control rate (DCR) | Phase 1a/1b | Up to 48 months |
| Incidence of TEAEs | Phase 1b | Up to 48 months |
| Incidence of AESIs | Phase 1b | Up to 48 months |
| Incidence of DLTs | Phase 1b - Arms B and C | Up to 48 months |
| John Theurer Cancer Center Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14203 | United States |
|
| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
|
| LDS Hospital | Recruiting | Salt Lake City | Utah | 84143 | United States |
|
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| 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 |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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