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

Fallopian Tube Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469281
• Other study ID #: 27T51-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 28, 2024
• Est. completion date: June 29, 2029

Study information

• Verified date: June 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

Former Sponsor 2seventy bio

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 29, 2029
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status = 1

2. Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification

3. Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol

4. 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

5. Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.

6. Expected survival = 3 months

Key Exclusion Criteria:

1. Inadequate cardiovascular, renal and hepatic function, as described in the protocol

2. Absolute lymphocyte count (ALC) < 100 cells/µL at time of leukapheresis

3. History of Grade = 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol

4. Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol

5. 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)

6. Treatment with any cellular or gene therapy Note: Other protocol-defined Inclusion/Exclusion criteria apply

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Other:
• 27T51
Intravenous (IV) infusion

Drug:
• Cemiplimab
IV infusion
• Bevacizumab
IV Infusion

Locations

Country	Name	City	State
United States	John Theurer Cancer Center Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events (TEAEs)	Part 1a	Up to 18 months
Primary	Incidence of adverse events of special interest (AESIs)	Part 1a	Up to 18 months
Primary	Incidence of adverse events of dose limiting toxicities (DLTs)	Part 1a	Up to 18 months
Primary	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.	Up to 3 years
Primary	Overall response rate (ORR) as assessed by the investigator	Phase 1b	Up to 48 months
Secondary	ORR as assessed by the investigator	Phase 1a	Up to 48 months
Secondary	Duration of response (DoR)	Phase 1a/1b	Up to 48 months
Secondary	Disease control rate (DCR)	Phase 1a/1b	Up to 48 months
Secondary	Incidence of TEAEs	Phase 1b	Up to 48 months
Secondary	Incidence of AESIs	Phase 1b	Up to 48 months
Secondary	Incidence of DLTs	Phase 1b - Arms B and C	Up to 48 months