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CAR T-cell Therapy
27T51 Therapy for Ovarian Cancer
Phase 1
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new type of therapy called 27T51, which is a treatment that targets a specific protein in the immune cells to fight ovarian and related cancers. The study has two main
Who is the study for?
This trial is for adult women with recurrent or hard-to-treat ovarian, primary peritoneal, or fallopian tube cancer. Participants should have tried other treatments that didn't work well. The study will exclude certain individuals based on specific medical criteria not listed here.
What is being tested?
The trial is testing a new CAR T cell therapy called 27T51 alone and in combination with Cemiplimab and Bevacizumab. It has two parts: finding the highest safe dose (Phase 1a) and then using this dose to further evaluate safety and effectiveness (Phase 1b).
What are the potential side effects?
Potential side effects of CAR T cell therapies like 27T51 can include flu-like symptoms, fatigue, fever, difficulty breathing, changes in blood pressure, and allergic reactions. Side effects from Cemiplimab may involve skin reactions or immune system-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is ovarian, peritoneal, or fallopian tube and has come back or didn't respond to treatment.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My CA 125 levels are twice as high as the normal limit.
Select...
I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had serious bleeding or blood clotting issues in the last month.
Select...
I have a known brain condition that is significant.
Select...
I have not undergone any cell or gene therapy treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events of dose limiting toxicities (DLTs)
Incidence of adverse events of special interest (AESIs)
Incidence of treatment emergent adverse events (TEAEs)
+2 moreSecondary study objectives
Disease control rate (DCR)
Duration of response (DoR)
Incidence of AESIs
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Expansion - Arm CExperimental Treatment3 Interventions
27T51+Cemiplimab+Bevacizumab
Group II: Dose Expansion - Arm BExperimental Treatment2 Interventions
27T51+Cemiplimab
Group III: Dose Expansion - Arm AExperimental Treatment1 Intervention
27T51 monotherapy
Group IV: Dose EscalationExperimental Treatment1 Intervention
27T51 monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470
Bevacizumab
2013
Completed Phase 4
~5540
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,734 Total Patients Enrolled
3 Trials studying Ovarian Cancer
928 Patients Enrolled for Ovarian Cancer
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,827 Total Patients Enrolled
1 Trials studying Ovarian Cancer
612 Patients Enrolled for Ovarian Cancer