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CAR T-cell Therapy
CATCH T Cells for Solid Cancers
Phase 1
Recruiting
Led By Tannaz Armaghany, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lansky or Karnofsky score ≥ 60%
platelet count > 25,000/μl (can be transfused)
Must not have
Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
Uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to fight cancer by genetically engineering patients' T cells to better target and kill their tumor cells.
Who is the study for?
Adults with certain solid tumors like liver cancer, who have tried standard treatments without success or can't receive them. They must be in relatively good health with a life expectancy of at least 12 weeks and adequate organ function. Pregnant individuals, those with HIV, active infections (except Hepatitis B/C), or history of organ transplant cannot participate.
What is being tested?
The trial is testing CATCH T cells, which are the patient's own immune cells genetically modified to target and kill cancer cells by recognizing a protein called GPC3 on tumor surfaces. The study aims to determine the highest safe dose, how long these cells last in the body, their side effects, and effectiveness against GPC3-positive tumors.
What are the potential side effects?
Potential side effects include reactions related to immune response such as fever or fatigue; risk of infection; possible damage to non-cancerous tissues that also carry the GPC3 protein; and other unforeseen complications due to genetic modification of T cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
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My platelet count is above 25,000, or I can receive a transfusion to reach it.
Select...
I can care for myself but may need occasional help.
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My kidneys are functioning well, with a creatinine clearance rate of 60 ml/min or higher.
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My liver is functioning well enough for treatment.
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My condition did not improve after initial and at least one follow-up treatment.
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I am 18 years old or older.
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My tumor is GPC3-positive and has relapsed or is not responding to treatment.
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I am 18 years old or older.
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I have recovered from the side effects of my previous cancer treatments.
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My bilirubin levels are less than three times the upper limit.
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My liver cancer is at an early to intermediate stage.
Select...
My liver is functioning well enough for treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any active infections, except possibly Hepatitis B or C.
Select...
I do not have any infections that are not responding to treatment.
Select...
I am allergic to mouse protein products or have human anti-mouse antibodies.
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I have had an organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients with Dose Limiting Toxicity
Secondary study objectives
Median T cell persistence
Percent of Patients with best response as either complete response or partial response
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CATCH T cellsExperimental Treatment1 Intervention
GPC3-CAR and the IL15 (CATCH T cells) will be administered to patients with GPC3-positive solid tumors.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
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6,029,468 Total Patients Enrolled
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The Methodist Hospital Research InstituteOTHER
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110 Patients Enrolled for Rhabdomyosarcoma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,828 Total Patients Enrolled
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on high doses of steroids or can stop them 24 hours before CAR T cell therapy.I can care for myself but may need occasional help.My platelet count is above 25,000, or I can receive a transfusion to reach it.I can care for myself but may need occasional help.My kidneys are functioning well, with a creatinine clearance rate of 60 ml/min or higher.My liver is functioning well enough for treatment.My condition did not improve after initial and at least one follow-up treatment.Your hemoglobin level is at least 7.0 grams per deciliter. If it is lower, you can receive a blood transfusion.I am 18 years old or older.You are expected to live for at least 12 more weeks.My tumor is GPC3-positive and has relapsed or is not responding to treatment.I agree to use effective birth control for 3 months after T-cell infusion.I am 18 years old or older.Your INR (International Normalized Ratio) blood test result should be 1.7 or lower, but this applies only to patients with liver cancer.Your oxygen level is above 90% when measured with a device called a pulse oximeter while breathing regular air.You need to have a certain level of a type of white blood cell called neutrophils in your blood.I have recovered from the side effects of my previous cancer treatments.Your AST levels in the blood are not more than 5 times the upper limit of normal.My bilirubin levels are less than three times the upper limit.You have been diagnosed with HIV.I do not have any active infections, except possibly Hepatitis B or C.I do not have any infections that are not responding to treatment.My liver cancer is at an early to intermediate stage.You are expected to live for at least 16 more weeks.My organs are working well.I am allergic to mouse protein products or have human anti-mouse antibodies.I have had an organ transplant.My liver is functioning well enough for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: CATCH T cells
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.
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