AP1903 for Metastatic HER2-negative Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic HER2-negative Breast Cancer+1 MoreAP1903 - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
Maximum tolerated does (MTD)

Trial Safety

Safety Progress

1 of 3

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 York100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
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%