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CAR T-cell Therapy
Immunotherapy for Cancer
Phase 1
Waitlist Available
Led By Andras Heczey, 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
Age ≥21 years
Lansky or Karnofsky score ≥60%
Must not have
Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
History of organ transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for solid tumors that combines antibodies and T cells. Antibodies are proteins that help protect the body from diseases, including cancer. T cells are special blood cells that can
Who is the study for?
Adults with certain solid tumors that test positive for a protein called GPC3 can join this trial. They should be at least 21 years old, have a reasonable quality of life score, and expect to live at least another 16 weeks. People with liver cancer must meet specific criteria related to their disease stage and liver function.
What is being tested?
The trial is testing a new type of T cell therapy called 21.15.GPC3-CAR T cells designed to target and kill tumor cells in adults with GPC3-positive solid tumors. These engineered T cells also carry genes that help them grow better and last longer in the body.
What are the potential side effects?
Potential side effects may include reactions from the engineered T cells such as fever, fatigue, or an overactive immune response which could affect normal organs. The study includes safety measures like using AP1903 drug if needed to stop the CAR T cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
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I can care for myself but may need occasional help.
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My liver cancer is at an early to intermediate stage.
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My tumor is GPC3-positive according to specific tests.
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 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 remission or partial remission
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: 21.15.GPC3-CAR T cellsExperimental Treatment1 Intervention
GPC3-CAR and the IL15 plus IL21 will be administered to patients with GPC3-positive solid tumors.
Find a Location
Who is running the clinical trial?
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,834 Total Patients Enrolled
3 Trials studying Liposarcoma
75 Patients Enrolled for Liposarcoma
Baylor College of MedicineLead Sponsor
1,025 Previous Clinical Trials
6,029,758 Total Patients Enrolled
3 Trials studying Liposarcoma
75 Patients Enrolled for Liposarcoma
Andras Heczey, MDPrincipal InvestigatorBaylor College of Medicine
4 Previous Clinical Trials
102 Total Patients Enrolled
2 Trials studying Liposarcoma
48 Patients Enrolled for Liposarcoma
David Steffin, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
48 Total Patients Enrolled
2 Trials studying Liposarcoma
48 Patients Enrolled for Liposarcoma