T-Cell Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byShanu Modi, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the safety of different doses of specially prepared T cells collected from the blood. The investigators want to find a safe dose of these modified T cells for patients who have metastatic HER2-negative breast cancer.

Eligibility Criteria

This trial is for adults with advanced HER2-negative breast cancer who've had at least one chemo treatment and whose disease has progressed. They must have finished any previous treatments, including immunotherapy, certain days before getting T-cells and agree to use contraception. People can't join if they're on daily steroids, have autoimmune diseases, are pregnant or breastfeeding, or have untreated brain metastases.

Inclusion Criteria

I finished chemotherapy at least a week ago.

I finished chemotherapy, targeted therapy, or radiotherapy at least 14 days ago and any immunotherapy over a month ago.

My breast cancer diagnosis was confirmed through a biopsy.

See 15 more

Exclusion Criteria

Pregnancy or lactation

I have not taken antibiotics for an infection in the last 7 days.

I have an autoimmune or antibody-mediated disease.

See 8 more

Treatment Details

Interventions

AP1903 (Other)
Cyclophosphamide (Alkylating agents)
Mesothelin-targeted T cells (CAR T-cell Therapy)

Trial OverviewThe study tests different doses of modified T cells targeting mesothelin in patients with metastatic breast cancer to find a safe level. Patients will receive Cyclophosphamide followed by the engineered T cells and AP1903 as part of the treatment process.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: T-cell infusionExperimental Treatment3 Interventions

A single blood volume leukapheresis for harvesting of PBMCs will be performed, As the transduced T cells will be frozen, the timing of leukapheresis is not defined \& can vary from patient to patient. Subsequently, a single dose of mesothelin-targeted T cells will be infused via intravenous catheter or central line (i.e., mediport). Patients will be monitored in the hospital and discharged home after a minimum of 48 hours. Patients will be monitored closely as outpatients for the next 2 months. Patients will be followed weekly as outpatients for the first 8 weeks after treatment. All patients will be hydrated intravenously, premedicated with acetaminophen \& diphenhydramine, \& administered cyclophosphamide at 1.5 g/m2 2 to 7 days (Day -7 to Day -2) before administration of mesothelin-targeted T cells.