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CAR T-cell Therapy
CAR T Cell Therapy for Breast Cancer
Phase 1
Recruiting
Led By Julia Tchou, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients with locally advanced unresectable or metastatic triple-negative breast cancer as confirmed by specific hormone receptor and HER2 status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial tests a new drug to make sure it's safe and if it works.
Who is the study for?
This trial is for adults over 18 with advanced triple-negative breast cancer that can't be removed by surgery or has spread, and whose tumors have a protein called mesothelin. They must be relatively healthy, not pregnant, and agree to use birth control. People with autoimmune diseases needing strong meds, other cancers, hepatitis B or C, serious infections or heart/lung problems can't join.Check my eligibility
What is being tested?
The study is testing the safety of a new therapy using CAR T cells (huCART-meso cells) designed to target mesothelin in breast cancer. It's an early-phase trial to see if this approach could work as a treatment. Participants will also undergo tests to confirm their tumor expresses mesothelin.See study design
What are the potential side effects?
Possible side effects may include reactions related to the immune system attacking normal cells while targeting cancer cells, such as inflammation in various organs. There might also be typical symptoms associated with cell therapies like fatigue, fever and chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My breast cancer is advanced, cannot be surgically removed, and lacks certain hormone receptors and HER2.
Select...
I have a tumor that can be reached for injection and removal.
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My tumor shows mesothelin in more than 10% of the cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.
Occurrence of treatment-limiting toxicities (TLTs)
Secondary outcome measures
Kinetics of expansion and persistence of infused cells by flow cytometry.
Kinetics of expansion and persistence of infused cells by quantitative PCR.
Proportion of eligible subjects that receive study treatment
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Level 1Experimental Treatment2 Interventions
3.00 x 10^7 CAR T cells administered intratumoral
Group II: Dose Level -1Experimental Treatment2 Interventions
3.00 x 10^6 CAR T cells administered intratumoral
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,221 Total Patients Enrolled
27 Trials studying Breast Cancer
26,348 Patients Enrolled for Breast Cancer
Julia Tchou, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an infection.I am fully active or can carry out light work.My organs and bone marrow are working well.My breast cancer is advanced, cannot be surgically removed, and lacks certain hormone receptors and HER2.My lungs are strong enough for treatment.I have a tumor that can be reached for injection and removal.I am 18 years old or older.I do not have serious heart problems that could interfere with the study.I am taking strong medication for an autoimmune disease.My tumor shows mesothelin in more than 10% of the cells.You have a current infection of hepatitis B or C.I do not have any active cancer other than the one targeted in this study.My cancer has spread to my brain or spinal cord.I do not have severe lung disease.Your heart's pumping ability is at least 45%, as confirmed by a heart ultrasound.I am scheduled to receive high dose corticosteroids.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1
- Group 2: Dose Level -1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any vacancies in this clinical trial available to new participants?
"The information on clinicaltrials.gov reveals that, as of November 11th 2022, this medical trial is no longer taking patients. However, 2600 other studies are still recruiting participants. The study was initially made public on January 1st 2023."
Answered by AI
Is Dose Level -1 considered a safe dosage for patients?
"Because the amount of data regarding safety and efficacy is limited, our team at Power assigned a rating 1 to Dose Level -1 in terms of its security."
Answered by AI
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