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
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. 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
Arms & interventions
- Other27T51
Intravenous (IV) infusion
- DrugCemiplimab
IV infusion
- DrugBevacizumab
IV Infusion
Outcome measures
Primary
Incidence of treatment emergent adverse events (TEAEs)
Part 1a
Time frame: Up to 18 months
Incidence of adverse events of special interest (AESIs)
Part 1a
Time frame: Up to 18 months
Incidence of adverse events of dose limiting toxicities (DLTs)
Part 1a
Time frame: 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.
Time frame: Up to 3 years
Overall response rate (ORR) as assessed by the investigator
Phase 1b
Time frame: Up to 48 months
Secondary
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
Eligibility criteria
Study locations (5)
Massachusetts General Hospital
Boston, Massachusetts, 02114
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601
Roswell Park Cancer Institute
Buffalo, New York, 14203
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
LDS Hospital
Salt Lake City, Utah, 84143