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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGJohn Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGRoswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGLDS Hospital
Salt Lake City, Utah, United States
RECRUITINGIncidence 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
ORR as assessed by the investigator
Phase 1a
Time frame: Up to 48 months
Duration of response (DoR)
Phase 1a/1b
Time frame: Up to 48 months
Disease control rate (DCR)
Phase 1a/1b
Time frame: Up to 48 months
Incidence of TEAEs
Phase 1b
Time frame: Up to 48 months
Incidence of AESIs
Phase 1b
Time frame: Up to 48 months
Incidence of DLTs
Phase 1b - Arms B and C
Time frame: Up to 48 months
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