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CAR T-cell Therapy

CAR T-Cell Therapy for Brain Metastasis

Phase 1

Recruiting

Led By Jana L Portnow

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has recurrent brain metastases after radiation therapy

Participant has untreated brain or leptomeningeal metastases and refuses to undergo radiation and/or intrathecal chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that involves delivering genetically-modified T cells into the brain. The goal is to find the best dose and to assess side effects.

Who is the study for?

This trial is for patients with recurrent brain or leptomeningeal metastases from HER2+ cancer, post-radiation therapy. They must have acceptable organ function, no severe heart issues, controlled seizures, not be on high-dose steroids or oxygen support, and agree to contraception if applicable. Excluded are those with active infections, other cancers, HIV, uncontrolled illnesses or requiring dialysis.Check my eligibility

What is being tested?

The study tests the safety and optimal dosage of HER2-CAR T cells injected into the brain's ventricles to target and destroy tumor cells in patients whose cancer has spread to the brain/leptomeninges and returned after treatment.See study design

What are the potential side effects?

Potential side effects may include immune reactions leading to inflammation in various organs (including the brain), infusion-related reactions such as fever or chills, fatigue due to immune system activation against cancer cells, and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain cancer has returned after radiation treatment.

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I have brain metastases and choose not to have radiation or chemotherapy.

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I am able to care for myself but may not be able to do active work.

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I take 6 mg or less of dexamethasone daily.

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I have a new or growing brain tumor, or cancer spread to the lining of my brain.

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My brain cancer has been treated and has not come back.

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I am willing to have a catheter placed for T cell collection if needed.

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I am taking 6 mg or less of dexamethasone daily during my CAR T cell therapy.

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I agree to pause my current cancer treatments for the first 3 cycles of the HER2-CAR T cell study.

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I don't have a fever above 38.5°C or any active infections.

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I don't need extra oxygen to maintain my oxygen levels above 95%.

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I have no history of severe heart failure or recent serious heart symptoms.

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My brain cancer has grown after radiation, or I have new brain tumors.

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I have a frozen HER2-CAR T cell treatment ready for use.

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My cancer is confirmed to be HER2 positive through testing.

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I do not have uncontrolled seizures after surgery before my first CAR T cell dose.

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My cancer has returned in the lining of my brain or spine after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose limiting toxicities (DLTs)

Number of participants with treatment related adverse events

Secondary outcome measures

Biomathematical modeling of tumor growth: perfusion and growth parameters based on serial brain magnetic resonance imaging

Circulating tumor cells in the CSF

Cytokine levels in CSF

+14 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (HER2-CAR T cells)Experimental Treatment1 Intervention

Patients receive HER2-CAR T cells via intraventricular administration over 5 minutes once weekly for 3 doses in the absence of disease progression or unacceptable toxicity. If patients continue to meet all eligibility criteria, they may receive additional cycles of HER2-CAR T cells at principal investigator's discretion.

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,329 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,321 Patients Enrolled for Breast Cancer

California Institute for Regenerative Medicine (CIRM)OTHER

63 Previous Clinical Trials

3,109 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,421 Total Patients Enrolled

42 Trials studying Breast Cancer

6,610 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to join this experiment?

"The prerequisites for being included in this clinical trial are a diagnosis of breast cancer and falling within the age range of 18 to 75. 39 participants must be recruited before it can begin."

Answered by AI

Does the FDA currently sanction Chimeric Antigen Receptor T-Cell Therapy?

"Due to a relative lack of supporting data, Chimeric Antigen Receptor T-Cell Therapy was assigned a rating of 1 for safety. This is because it remains in the early Phase 1 trial stage."

Answered by AI

Is this research initiative actively recruiting participants?

"Affirmative. According to clinicaltrials.gov, the trial which was initially listed on August 31st 2018 is still actively recruiting volunteers. There are 39 slots open at one medical centre."

Answered by AI

Is the study open to those who are over 75 years of age?

"Patients aged between 18 and 75 years are eligible to partake in this medical trial."

Answered by AI

How many participants are being invited to take part in this research endeavor?

"Affirmative, the data hosted on clinicaltrials.gov elucidates that this medical trial is presently recruiting patients. This research was initially posted on August 31st 2018 and has been edited as recently as September 14th 2022. There are 39 vacancies at a single site available for recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases

2018. "HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03696030.

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