Study Summary
This trial is testing the safety of different doses of T cells that have been collected from the blood and modified to target HER2-negative breast cancer cells. The goal is to find a safe dose of these modified T cells that can be used to treat patients with metastatic breast cancer.
Eligible Conditions
- Metastatic HER2-negative Breast Cancer
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 2 years
2 years
Maximum tolerated does (MTD)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
T-cell infusion
1 of 1
Experimental Treatment
186 Total Participants · 1 Treatment Group
Primary Treatment: AP1903 · No Placebo Group · Phase 1
T-cell infusionExperimental Group · 3 Interventions: AP1903, Mesothelin-targeted T cells, Cyclophosphamide · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimiducid
Not yet FDA approved
Cyclophosphamide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
United States Department of DefenseFED
779 Previous Clinical Trials
202,374 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,352 Total Patients Enrolled
Shanu Modi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
94 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have previously been treated with at least 1 chemotherapy regimen for metastatic disease and documented progression.
You have mesothelin expression.
Elevated serum SMRP levels (>1.0 nM/L) in patients with Cushing's disease.
You must have completed chemotherapy at least 7 days prior to leukapheresis.
You must have had a major operation at least 28 days before study enrollment.
Who else is applying?
What state do they live in?
| New York | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "i have tried other drugs so far and they haven't worked"
How many prior treatments have patients received?
| 3+ | 100.0% |
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Conditions
Cancer Related
Treatments