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Recruiting NCT06469281

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

Phase I Interventional Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 27T51, Cemiplimab, Bevacizumab.
Who it may be relevant to
Registry conditions: Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Other 27T51
    Intravenous (IV) infusion
  • Drug Cemiplimab
    IV infusion
  • Drug Bevacizumab
    IV Infusion

Primary outcome measures

  • Incidence of treatment emergent adverse events (TEAEs) [Time frame: Up to 18 months]
  • Incidence of adverse events of special interest (AESIs) [Time frame: Up to 18 months]
  • Incidence of adverse events of dose limiting toxicities (DLTs) [Time frame: Up to 18 months]
  • Manufacturing feasibility of 27T51 [Time frame: Up to 3 years]
  • Overall response rate (ORR) as assessed by the investigator [Time frame: Up to 48 months]
Secondary outcome measures (6)
  • 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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Massachusetts General Hospital — Boston
  • John Theurer Cancer Center Hackensack University Medical Center — Hackensack
  • Roswell Park Cancer Institute — Buffalo
  • UPMC Hillman Cancer Center — Pittsburgh
  • LDS Hospital — Salt Lake City

Identifiers

NCT: NCT06469281 · 27T51-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗