Epithelial Ovarian CancerPhase 1NCT06469281
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
A Phase 1 study testing 27T51, Cemiplimab and Bevacizumab in people with Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma, run by Regeneron Pharmaceuticals at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- What is being tested?
- 27T51, Cemiplimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Aug 2024to 27 May 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
- Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
- Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at the local lab by a 510(k) cleared test at screening
- Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.
- Expected survival ≥ 3 months
Who cannot join
- Inadequate cardiovascular, renal and hepatic function, as described in the protocol
- Absolute lymphocyte count (ALC) < 100 cells/μL at time of leukapheresis
- History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
- Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune related adverse events (AEs)
- Treatment with any cellular or gene therapy
- Note: Other protocol-defined Inclusion/Exclusion criteria apply
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Oladapo Yeku, MD, FACP, 617-643-9354
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14203
Laura Ryan, 716-845-3057 ext. 7298, Laura.Ryan@RoswellPark.org
- Recruiting
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
878-261-6063, IDDCReferrals@upmc.edu
- Recruiting
LDS Hospital
Salt Lake City, Utah, 84143
Joshua Kunz, 801-408-4724, joshua.kunz@imail.org
About this study
Official title: A Phase 1a/1b Study of 27T51, an Anti-MUC16 CAR T Cell Drug Product Administered Alone or in Combination for Participants With Recurrent or Refractory Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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:
Read more
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.
Read the detailed description
Former Sponsor 2seventy bio
- Being tested
- 27T51, Cemiplimab, Bevacizumab
- Keywords
- Ovarian Cancer, CAR T, Peritoneal, Fallopian Tube, MUC16, Immunotherapy
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
27T51Other
Intravenous (IV) infusion
CemiplimabDrug
Also called Libtayo, REGN2810
IV infusion
BevacizumabDrug
Also called Avastin, Mvasi, Vegzelma, Zirabe
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 27T51 monotherapy Receives: Other: 27T51 |
| Dose Expansion - Arm A | Experimental | 27T51 monotherapy Receives: Other: 27T51 |
| Dose Expansion - Arm B | Experimental | 27T51+Cemiplimab Receives: Other: 27T51; Drug: Cemiplimab |
| Dose Expansion - Arm C | Experimental | 27T51+Cemiplimab+Bevacizumab Receives: Other: 27T51; Drug: Cemiplimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs)
Part 1a
Measured: Up to 18 months
Incidence of adverse events of special interest (AESIs)
Part 1a
Measured: Up to 18 months
Incidence of adverse events of dose limiting toxicities (DLTs)
Part 1a
Measured: 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.
Measured: Up to 3 years
Overall response rate (ORR) as assessed by the investigator
Phase 1b
Measured: Up to 48 months
Secondary outcomes (6)
ORR as assessed by the investigator
Phase 1a
Measured: Up to 48 months
Duration of response (DoR)
Phase 1a/1b
Measured: Up to 48 months
Disease control rate (DCR)
Phase 1a/1b
Measured: Up to 48 months
Incidence of TEAEs
Phase 1b
Measured: Up to 48 months
Incidence of AESIs
Phase 1b
Measured: Up to 48 months
Incidence of DLTs
Phase 1b - Arms B and C
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start6 Aug 2024
- Primary completion27 May 2030 (estimated)
- Study completion27 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469281
- Sponsor's protocol ID
- 27T51-01
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study of 27T51, an Anti-MUC16 CAR T Cell Drug Product Administered Alone or in Combination for Participants With Recurrent or Refractory Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT06469281
- Acronym / sponsor ID
- 27T51-01
- Keywords
- Ovarian Cancer, CAR T, Peritoneal, Fallopian Tube, MUC16, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 27 May 2030 (estimated)
- Study completion
- 27 May 2030 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Former Sponsor 2seventy bio
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Other: 27T5127T51 monotherapy |
| Dose Expansion - Arm A | Experimental | Other: 27T5127T51 monotherapy |
| Dose Expansion - Arm B | Experimental | Other: 27T51, Drug: Cemiplimab27T51+Cemiplimab |
| Dose Expansion - Arm C | Experimental | Other: 27T51, Drug: Cemiplimab, Drug: Bevacizumab27T51+Cemiplimab+Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
- Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
- Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at the local lab by a 510(k) cleared test at screening
- Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.
Key exclusion criteria (7 listed)
- Inadequate cardiovascular, renal and hepatic function, as described in the protocol
- Absolute lymphocyte count (ALC) < 100 cells/μL at time of leukapheresis
- History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
- Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune related adverse events (AEs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 27T51Intravenous (IV) infusion | Other | Dose Escalation, Dose Expansion - Arm A, Dose Expansion - Arm B, Dose Expansion - Arm C |
| CemiplimabAlso: Libtayo, REGN2810IV infusion | Drug | Dose Expansion - Arm B, Dose Expansion - Arm C |
| BevacizumabAlso: Avastin, Mvasi, Vegzelma, ZirabeIV Infusion | Drug | Dose Expansion - Arm C |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 18 months
Part 1a
Incidence of adverse events of special interest (AESIs)
Time frame: Up to 18 months
Part 1a
Incidence of adverse events of dose limiting toxicities (DLTs)
Time frame: Up to 18 months
Part 1a
Manufacturing feasibility of 27T51
Time frame: Up to 3 years
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.
Overall response rate (ORR) as assessed by the investigator
Time frame: Up to 48 months
Phase 1b
6 secondary outcomes
ORR as assessed by the investigator
Time frame: Up to 48 months
Duration of response (DoR)
Time frame: Up to 48 months
Disease control rate (DCR)
Time frame: Up to 48 months
Incidence of TEAEs
Time frame: Up to 48 months
Incidence of AESIs
Time frame: Up to 48 months
Incidence of DLTs
Time frame: Up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 27T51, Cemiplimab and Bevacizumab in people with Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma, run by Regeneron Pharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (TEAEs) (time frame: Up to 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.