Actively Recruiting
Immunotherapy For Adults With GPC3-Positive Solid Tumors Using Interleukin-15 And -21 Armored Glypican-3-Specific Chimeric Antigen Receptor Expressing Autologous T Cells
Led by Baylor College of Medicine · Updated on 2025-11-03
21
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
C
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new immunotherapy treatment for adults with solid tumors that express the protein glypican-3 (GPC3) on their surface. This study explores genetically engineered T cells called 21.15.GPC3-CAR T cells, which are designed to better recognize and kill cancer cells. These T cells have been modified with additional genes, IL15 and IL21, to help them grow and stay active longer in the body. The study also includes a safety feature allowing the removal of these T cells if severe side effects occur using an experimental drug called AP1903. The treatment process involves collecting blood from participants to grow and genetically modify their T cells in the laboratory. Before receiving the T-cell infusion, participants undergo chemotherapy with cyclophosphamide and fludarabine to reduce their existing T cells, allowing the new T cells to grow better. The modified T cells are then infused into the participant 48 to 72 hours after chemotherapy. This is a dose escalation study where different doses of the 21.15.GPC3-CAR T cells will be tested to find a safe level. Participants may receive additional infusions if their condition does not worsen after 4 weeks. During the study, participants will have regular medical exams, blood tests, tumor scans, and biopsies to monitor safety and treatment effects. Blood samples will be collected at multiple time points up to 15 years to study how long the modified T cells last and if there are long-term side effects. The study team will also monitor tumor markers and overall health, with yearly follow-ups after the initial treatment period. The total participation time is up to 15 years to ensure comprehensive long-term monitoring.
CONDITIONS
Brief Title
Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of GPC3-positive solid tumors confirmed by immunohistochemistry with at least 25% positive tumor cells and intensity score of 2 or higher
- Age 21 years or older
- Lansky or Karnofsky score of 60% or higher
- Life expectancy of at least 12 weeks
- Barcelona Clinic Liver Cancer Stage A, B, or C with Child-Pugh-Turcotte score less than 7 (for hepatocellular carcinoma patients only)
- Adequate organ function including creatinine clearance at least 60 ml/min, total bilirubin less than 3 times the upper limit of normal, INR less than or equal to 1.7, neutrophil count above 500/µl, platelet count above 25,000/µl (can be transfused), hemoglobin of at least 7.0 g/dl (can be transfused), and pulse oximetry above 90% on room air
- Refractory or relapsed disease after prior therapies
- Recovered from acute toxic effects of prior chemotherapy and investigational agents
- Use of effective birth control methods for 3 months after T-cell infusion if sexually active
- Informed consent obtained and understood by patient or guardian
You will not qualify if you...
- History of hypersensitivity to murine protein-containing products or presence of human anti-mouse antibody prior to enrollment
- History of organ transplantation
- Known HIV positivity
- Active bacterial, fungal, or viral infection (except Hepatitis B or C virus infections)
- Pregnancy or lactation
- Uncontrolled infection
- Systemic steroid treatment at doses of 0.5 mg prednisone equivalent/kg/day or higher within 24 hours prior to CAR T-cell infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Standard medical tests including physical exam, blood tests, pregnancy test if applicable, scans to measure tumor size, and tumor marker tests if applicable.
Duration - 3 days
Participants receive chemotherapy with cyclophosphamide and fludarabine for 3 days to prepare their body for the CAR T cell infusion by decreasing their existing T cells.
3 daily visits (in-person) for chemotherapy administration
Duration - Single infusion with possibility of up to one additional infusion after 4 weeks if condition does not worsen
Participants receive an infusion of genetically engineered 21.15.GPC3-CAR T cells approximately 48 to 72 hours after completing chemotherapy. The infusion lasts 5 to 10 minutes, and pre-medications may be given to prevent allergic reactions.
1 infusion visit (in-person) plus pre-medication and monitoring during and after infusion
Duration - Up to 15 years
Participants undergo physical exams, blood tests, tumor scans, and tumor biopsies as clinically indicated to monitor treatment effects and safety. Blood samples are taken at specified intervals to study the activity and persistence of the CAR T cells.
Multiple visits including assessments at 1, 2, 4, and 8 weeks post-infusion; every 3 months for 1 year; every 6 months for 4 years; then annually up to 15 years
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Premal Lulla, MD
D
David Steffin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here