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90 Participants Needed

27T51 Therapy for Ovarian Cancer

Recruiting at 3 trial locations

Overseen ByClinical Trials Administrator

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Immunosuppressants, Gene therapy

Disqualifiers: Inadequate organ function, CNS pathology, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on treatments for autoimmune diseases or have had cellular or gene therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment 27T51, Anti-MUC16 CAR T-cells 27T51, for ovarian cancer?

Research shows that CAR T-cells targeting MUC16, a protein found on ovarian cancer cells, have been effective in preclinical models, reducing tumor size and improving survival in mice. This suggests that targeting MUC16 with CAR T-cells could be a promising approach for treating ovarian cancer.¹ ² ³ ⁴ ⁵

What safety data exists for 27T51 Therapy for Ovarian Cancer?

The research indicates that CAR T-cell therapies, like 27T51, have potential side effects such as cytokine-associated and 'on-target, off-tumor' toxicities, which means the treatment might affect healthy cells as well as cancer cells. An elimination gene has been included in some CAR T-cell constructs to allow for the removal of these cells if unforeseen toxicities occur.¹ ² ³ ⁴ ⁵

What makes the 27T51 treatment unique for ovarian cancer?

The 27T51 treatment is unique because it uses engineered T cells to target ovarian cancer cells by recognizing specific proteins on their surface, such as MUC16, and also secretes a special molecule to recruit other immune cells to attack the cancer, making it more effective than treatments targeting a single protein.¹ ² ³ ⁴ ⁶

What is the purpose of this trial?

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.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

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

My cancer is ovarian, peritoneal, or fallopian tube and has come back or didn't respond to treatment.

Expected survival ≥ 3 months

See 3 more

Exclusion Criteria

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

I haven't had serious bleeding or blood clotting issues in the last month.

I have a known brain condition that is significant.

See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Dose Escalation

Test the safety of 27T51 in a small number of participants to find the highest dose without unacceptable side effects

Up to 18 months

Phase 1b Dose Expansion

Test 27T51 at the established dose level(s) and may include other medications given in combination

Up to 48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

27T51

Trial Overview 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).

Participant Groups

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Findings from Research

The study developed a novel CAR T cell therapy targeting the MUC-16ecto antigen in ovarian cancer, showing that the addition of IL-12 enhances T cell proliferation and IFNγ secretion, leading to improved antitumor efficacy in mouse models.

To ensure safety in potential clinical applications, the CAR T cells include an elimination gene that allows for their removal in case of unexpected side effects, making this approach both innovative and cautious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL-12 secreting tumor-targeted chimeric antigen receptor T cells eradicate ovarian tumors in vivo.Koneru, M., Purdon, TJ., Spriggs, D., et al.[2021]

Engineered CAR T cells targeting both Muc16 and WT1 antigens in ovarian cancer show enhanced anticancer activity, especially against tumors with low Muc16 expression, indicating a promising approach to overcome treatment resistance.

The use of a bispecific T cell engager (BiTE) allows these CAR T cells to recruit additional T cells to attack cancer cells, enhancing the overall effectiveness of the therapy in both laboratory and mouse models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual targeting ovarian cancer by Muc16 CAR T cells secreting a bispecific T cell engager antibody for an intracellular tumor antigen WT1.Mun, SS., Meyerberg, J., Peraro, L., et al.[2023]

The use of a bispecific T cell engager (BiTE) allows these CAR T cells to recruit additional T cells to attack cancer cells, demonstrating a novel strategy to overcome the limitations of traditional CAR T cell therapies in heterogeneous tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual targeting ovarian cancer by Muc16 CAR-T cells secreting a bispecific T cell engager antibody for an intracellular tumor antigen WT1.Mun, SS., Peraro, L., Meyerberg, J., et al.[2023]