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CAR T-cell Therapy
CAR T-Cell Therapy for Thyroid Cancer
Phase 1
Recruiting
Led By Roger Cohen, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
Incurable recurrent/metastatic disease that is progressive after at least 1 prior tyrosine kinase inhibitor (TKI) containing regimen, or the patient was intolerant of or declined such therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial is testing a new treatment for thyroid cancer that uses a patient's own T cells.
Who is the study for?
Adults over 18 with incurable medullary thyroid cancer (MTC) that's worsened after treatment or if they couldn't tolerate the therapy. They must have good organ function, not be on dialysis, and have a stable heart and lung condition. Pregnant women, those with severe allergies to trial drugs' components, active infections like hepatitis B/C, unstable heart conditions or seizures can't join.Check my eligibility
What is being tested?
The study is testing CART-GFRa4 cells in patients with MTC who haven't responded to other treatments. It involves modifying a patient's T cells to target cancer cells more effectively. The safety of this approach combined with Fludarabine and Cyclophosphamide chemotherapy is being evaluated.See study design
What are the potential side effects?
Potential side effects include immune reactions from modified T-cells attacking normal tissue, infusion-related symptoms such as fever or chills, bone marrow suppression from chemotherapy leading to increased infection risk or bleeding tendencies, fatigue, nausea and potential liver toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild or no shortness of breath and my oxygen level is above 92% without assistance.
Select...
My cancer has returned or spread and got worse after TKI treatment, or I couldn't tolerate or chose not to have TKI therapy.
Select...
My kidneys work well enough, not requiring dialysis.
Select...
My thyroid cancer diagnosis was confirmed through tissue examination.
Select...
Side effects from my previous treatments have mostly gone away.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
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.
Secondary outcome measures
Best Overall Response (BOR)
Duration of Response (DOR)
Number of subjects who have a response
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 3: single fixed dose of 3x10^8 CART-GFRa4 cells via intravenous infusionExperimental Treatment3 Interventions
Group II: Cohort 2: single dose of 1x10^8 CART-GFRa4 cells via intravenous infusionExperimental Treatment3 Interventions
Group III: Cohort 1: single dose of 5x10^7 CART-GFRa4 cells via intravenous infusionExperimental Treatment3 Interventions
Group IV: Cohort -1: single dose of 2x10^7 CART-GFRa4 cells via intravenous infusionExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,215 Total Patients Enrolled
Roger Cohen, MDPrincipal InvestigatorUniversity of Pennsylvania
4 Previous Clinical Trials
242 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping ability, measured by ECHO or MUGA, is at least 45%.My liver tests are within the required limits, except I have Gilbert's syndrome.I have mild or no shortness of breath and my oxygen level is above 92% without assistance.You have a skin rash or allergies that need strong medicine to treat.My cancer has returned or spread and got worse after TKI treatment, or I couldn't tolerate or chose not to have TKI therapy.My kidneys work well enough, not requiring dialysis.My thyroid cancer diagnosis was confirmed through tissue examination.I have a seizure disorder or have had seizures that needed medication.I am not on high-dose steroids for an autoimmune disease like MS or Parkinson's.I do not have a history of brain or spinal cord involvement with my cancer.Side effects from my previous treatments have mostly gone away.I am allergic to some ingredients in the study medication.I am fully active or can carry out light work.I am on a low dose of steroids or may use inhaled steroids, but not high dose treatments.I have severe heart condition limitations.I haven't taken immune checkpoint inhibitors in the last 2 months.Your disease must be measurable according to a specific set of guidelines.My heart rhythm problem is not controlled with medication.My kidney function is reduced but not severely (moderate impairment).I do not have any ongoing, untreated infections.I have had serious lung inflammation before.You currently have an active hepatitis B or C infection.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: single dose of 5x10^7 CART-GFRa4 cells via intravenous infusion
- Group 2: Cohort -1: single dose of 2x10^7 CART-GFRa4 cells via intravenous infusion
- Group 3: Cohort 2: single dose of 1x10^8 CART-GFRa4 cells via intravenous infusion
- Group 4: Cohort 3: single fixed dose of 3x10^8 CART-GFRa4 cells via intravenous infusion
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
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.
Has the solitary administration of CART-GFRa4 cells been accepted by the FDA?
"CART-GFRa4 cells have not yet been extensively tested, which is why they received a score of 1. This single dose study aims to elucidate the safety and efficacy of this potential treatment."
Answered by AI
Are there any slots still open for participation in this clinical research?
"According to the records on clinicaltrials.gov, this clinical trial is still in search of participants. It was initially posted on August 19th 2021 and updated for the final time on September 16th 2022."
Answered by AI
To what malady are CART-GFRa4 cells usually administered in a single dose?
"CART-GFRa4 cells administered in a single dose is usually given to patients with multiple sclerosis. This medical therapy also has the potential to help individuals who are suffering from mixed cell lymphoma, leukemia, myelocytic acute and retinoblastomas."
Answered by AI
How many participants has this trial reached capacity for?
"Indeed, clinicaltrials.gov confirms that this medical experiment is currently enrolling participants. Initially published on August 19th 2021, the study requires 18 individuals from one site in order to be completed."
Answered by AI
To what extent have prior trials assessed the efficacy of a solitary injection of CART-GFRa4 cells?
"Currently, 889 clinical trials have been initiated to study the efficacy of a single dose of CART-GFRa4 cells; 161 are in Phase 3. These investigations are taking place across 28446 sites with many based out of Philadelphia, Pennsylvania."
Answered by AI
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