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CAR T-cell Therapy

HER2 BATs + Pembrolizumab for Breast Cancer (Breast-47 Trial)

Phase 1 & 2

Recruiting

Led By Patrick Dillon, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients are required to have at least one measurable non-bone lesion ≥10 mm that has not been irradiated.

Female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 4.5.2, for the course of the study through 120 days after the last dose of study medication.

Must not have

Has an active infection requiring systemic therapy.

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood will be collected about 5 weeks before any treatment, just before first her2 bats infusion, before her2 bats #5, before her2 bats #8, and 2 weeks, 1 month, 3 months, and 6 months after last pembrolizumab

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test a new treatment for breast cancer that uses a combination of 8 infusions of BATs and one to three infusions of PBZ. The goal is to determine if this is a safe and effective treatment for breast cancer.

Who is the study for?

This trial is for women over 18 with metastatic breast cancer who have had at least two prior treatments. They must have measurable disease, a life expectancy of more than 3 months, and be able to undergo apheresis. HER2 status can be positive or negative. Participants need functioning major organs and cannot be pregnant or breastfeeding. Exclusions include hypersensitivity to pembrolizumab, certain recent vaccines, active autoimmune diseases requiring treatment in the past two years, other cancers within five years (with some exceptions), and untreated brain metastases.

What is being tested?

The study tests HER2Bi armed activated T-cells (HER2 BATs) combined with pembrolizumab on women with metastatic breast cancer. Phase I determines the safe dose for up to 18 patients; phase II treats an additional 12 patients at this dose to assess safety and effectiveness. The treatment involves eight infusions of BATs plus one to three doses of pembrolizumab in different schedules.

What are the potential side effects?

Potential side effects may include immune reactions due to T-cell activation, infusion-related responses from both therapies, fatigue from the body's response to treatment, possible organ inflammation caused by pembrolizumab's effect on the immune system, as well as risks associated with any form of immunotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor larger than 10 mm that has not been treated with radiation.

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I agree to use birth control during and up to 120 days after the study.

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I have undergone at least two treatments for cancer that has spread.

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I have a tumor that can be measured and has not been treated with radiation.

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I am a woman and I am 18 years old or older.

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I am fully active or can carry out light work.

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My breast cancer has spread, and this was confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have a history of serious heart problems.

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I have or had lung inflammation not caused by an infection.

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I have mostly recovered from side effects of my last cancer treatment, except for mild neuropathy.

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I have not needed systemic treatment for an autoimmune disease in the last 2 years.

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I have a history of active tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood will be collected about 5 weeks before any treatment, just before first her2 bats infusion, before her2 bats #5, before her2 bats #8, and 2 weeks, 1 month, 3 months, and 6 months after last pembrolizumab

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood will be collected about 5 weeks before any treatment, just before first her2 bats infusion, before her2 bats #5, before her2 bats #8, and 2 weeks, 1 month, 3 months, and 6 months after last pembrolizumab

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood will be collected about 5 weeks before any treatment, just before first her2 bats infusion, before her2 bats #5, before her2 bats #8, and 2 weeks, 1 month, 3 months, and 6 months after last pembrolizumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicities on each schedule/arm

Secondary study objectives

Disease control rate

Dose Limiting Toxicities on the selected arm in the expansion cohort

Duration of response

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Schedule #3Experimental Treatment1 Intervention

At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7.

Group II: Schedule #2Experimental Treatment1 Intervention

At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7.

Group III: Schedule #1Experimental Treatment1 Intervention

At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4.

0 / 14Eligibility criteria met