cMet CAR RNA T Cells Targeting Breast Cancer

June 20, 2023 updated by: University of Pennsylvania

Clinical Trial of Autologous cMet Redirected T Cells Administered Intratumorally in Patients With Breast Cancer

An open-label, clinical trial of autologous cMet redirected T cells administered intratumorally (IT) in patients with breast cancer. Fifteen evaluable patients will be enrolled in stepwise fashion. Step 1 will enroll patients with metastatic breast cancer refractory to at least 1 standard therapy, step 2 will include newly diagnosed patients with operable triple negative breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to determine the safety and feasibility of intratumoral administration of autologous T cells that have had genetic material transferred into the cell to redirect them to target breast cancer cells rather than their usual target. Eligible subjects will have metastatic breast cancer refractory to at least one standard therapy or to newly diagnosed with operable triple negative breast cancer.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Step 1 subjects only: metastatic breast cancer patients with an accessible tumor (cutaneous, subcutaneous, or superficial) and/or palpable adenopathy/mass. The targeted tumor is accessible (i.e. is not near a great vessel or the spinal cord) and can be surgically excised or biopsied.
  • Step 2 subjects only: Newly diagnosed, operable, triple negative breast cancer, i.e. ER/PR-negative, her2/neu-negative, with tumor size between 2 - 3 cm (T2) as measured by either clinical breast exam, mammogram, ultrasound or MRI, with or without ipsilateral axilla node involvement (N0 or N1).
  • cMet expression in ≥ 30% tumor cells as demonstrated on immuno-histochemistry analysis of archival slides. The intensity for cMet IHC should be greater than or equal to 1+. Punch biopsy or percutaneous core biopsy may be offered to Cohort 1 patients. To establish eligibility for patients in step 1, archival tumor tissues from any previously biopsied metastatic tumor deposit may be used for IHC staining. The metastatic tumor nodule to be targeted for IT injection may not necessarily be the same as previously biopsied metastatic site.
  • Age > 18 years old
  • Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1
  • Adequate hematologic function:

WBC > 3.0 Plt > 75,000 Hgb > 10 g/dl Adequate renal function defined as serum creatinine < 1.5 times upper limit of normal

- Adequate hepatic function defined as: Total bilirubin < 1.5 times upper limit of normal, and ALT and AST < 2.5 times upper limit of normal

  • Women of child bearing potential must have a negative pregnancy test (blood or urine) and agree to use appropriate contraception from study screen through the duration of the trial. Men must agree to use appropriate contraception from IT injection through the duration of the trial.
  • Signed and dated written informed consent.

Exclusion Criteria:

  • Step 1 subjects only: Targeted tumor near a great vessel or spinal cord
  • Step 2 subjects only: Women already undergoing neoadjuvant chemotherapy to treat their primary triple negative breast cancer
  • Step 1 and 2 subjects:Positive for HIV-1/HIV-2
  • Active hepatitis B or hepatitis C infection
  • The anticipated use of the following within 2 weeks prior to apheresis and prior to planned IT T-cell injection:

Immunosuppressive drugs Cytotoxic chemotherapy (See Section 5.7 for complete details) Systemic glucocorticoids (steroid prep due to dye allergies prior to staging scans or use in anti-emetic prophylaxis for patients undergoing chemotherapy is allowed) Hematopoietic growth factors Other experimental therapy Note: Step 1 patients receiving non-investigational targeted therapy (lapatinib, trastuzumab, and/or pertuzumab) are eligible provided these medicines are at a stable dose and the patient began taking them more than 30 days prior to the planned IT T-cell injection.

  • Anticipated use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before the planned IT T-cell injection RETIRED AS OF PROTOCOL VERSION 11
  • Pregnant women or nursing mothers
  • History of alcohol abuse or illicit drug use within 12 months of IT T-cell injection
  • Clinically significant comorbid disease or other underlying condition, including major autoimmune disorders that would contraindicate study therapy or confuse interpretation of study results
  • Significant psychiatric disorder and any other reason that in the Investigator's opinion would jeopardize protocol compliance or compromise the patient's ability to give informed consent.
  • Prior MI ascertained from medical history and review of systems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cMet positive breast cancer patients
Metastatic breast cancer patients with an accessible tumor (cutaneous, subcutaneous, or superficial) and/or a palpable adenopathy/mass, with ≥ 30% tumor cells expressing cMet as demonstrated on immunohistochemical analysis . The intensity for cMet IHC should be greater than or equal to 1+. The targeted tumor must be accessible (i.e. is not near a great vessel or the spinal cord) and can be surgically excised or biopsied.
Biological: cMet RNA CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Serious Adverse Event
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Julia Tchou, MD, Abramson Cancer Center at Penn Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 13, 2018

Study Completion (Actual)

August 13, 2018

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimated)

April 23, 2013

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 13111, 813858

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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