Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Metastatic HER2-negative Breast

Keywords

T-CellChimeric antigen receptor (CAR)CAR T cellsTriple-negative breast cancerImmunotherapy T-cell therapy16-040immunotherapyCAR

Outcome Measures

Primary Outcomes (1)

Maximum tolerated does (MTD)
We have designed the dose-escalation using a standard 3+3 design. In this design, patients will be treated in sequential groups of 3 to 6 patients per T cell dose. With 4 dose levels, the projected trial size for this study is a minimum of 4 and a maximum of 24 patients.
2 years

Study Arms (1)

T-cell infusion

EXPERIMENTAL

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.

Drug: CyclophosphamideBiological: Mesothelin-targeted T cellsDrug: AP1903

Interventions

CyclophosphamideDrug

T-cell infusion

Mesothelin-targeted T cellsBiological

T-cell infusion

AP1903

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients aged ≥18 years with metastatic breast cancer
Karnofsky performance status ≥70%

Sponsors & Collaborators

United States Department of Defense
US federal agencycollaborator
Memorial Sloan Kettering Cancer Center
Otherlead

Study Sites (7)

Memorial Sloan Kettering Cancer Center (Consent and follow-up only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent and follow-up only)

Middletown, New Jersey, 07748, United States

Memorial Sloan Kettering Bergen (Consent and follow-up only)

Montvale, New Jersey, 07645, United States

Memorial Sloan Kettering Cancer Center at Commack (Consent and follow-up only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent and follow-up only)

Harrison, New York, 10604, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

CyclophosphamideAP 1903 reagent

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard Compounds

Study Officials

Shanu Modi, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

186 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 7, 2016

Study Start

June 2016

Actual (reported)

Primary Completion

You may not qualify if:

Untreated or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control); patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met:
Presence of measurable or evaluable disease outside of the CNS;
Radiographic demonstration of improvement upon completion of CNS- directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study;
Completion of radiotherapy ≥8 weeks prior to the screening radiographic study;
Discontinuation of corticosteroids and anticonvulsants ≥4 weeks prior to the screening radiographic study.
History of seizure disorder
Patients currently receiving treatment for concurrent active malignancy. Prior immunotherapy with checkpoint blockade (i.e., PD1 inhibitor, PDL1 inhibitor, or CTL4-antagonist or similar agent) must have been completed more than 1 month prior to the T-cell infusion.
Autoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (patients with a history of hypothyroidism will not be excluded)
Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease
Pregnant or lactating women
Known active infection requiring antibiotics within 7 days of the start of treatment (Day 0)
A requirement for daily systemic corticosteroids for any reason or a requirement for other immunosuppressive or immunomodulatory agents. Topical, nasal, and inhaled steroids are permitted.
Administration of live, attenuated vaccine within 8 weeks before the start of treatment (Day 0) and throughout the study
Any other medical condition that, in the opinion of the PI, may interfere with a subject's participation in or compliance with the study
Participation in a therapeutic research study or receipt of an investigational drug within 30 days of T-cell infusion

T-Cell Therapy for Advanced Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

T-cell infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

T-cell infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations