Actively Recruiting
HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma
Led by Baylor College of Medicine · Updated on 2026-01-22
25
Participants Needed
1
Research Sites
1125 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
The purpose of this study is to learn whether it is safe to give HER2-CAR T cells in combination with an immune checkpoint inhibitor drug (pembrolizumab or nivolumab), to learn what the side effects are, and to see whether this therapy might help patients with sarcoma. Another goal of this study is to study the bacteria found in the stool of patients with sarcoma who are being treated with HER2 CAR T cells and immune checkpoint inhibitor drugs to see if the types of bacteria influence how well the treatment works. The investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to see if they can put a new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new gene that the investigators will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor Receptor 2) that binds to sarcoma cells. In addition, it contains CD28, which stimulated T cells and make them last longer. After this new gene is put into the T cell, the T cell becomes known as a chimeric antigen receptor T cell or CAR T cell. In another clinical study using these CAR T cells targeting HER2 as well as other studies using CAR T cells, investigators found that giving chemotherapy before the T cell infusion can improve the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of the patient's lymphocytes first should allow the infused T cells to expand in the body, and potentially kill cancer cells more effectively. The chemotherapy used for lymphodepletion is a combination of cyclophosphamide and fludarabine. After the patient receives the lymphodepletion chemotherapy and CAR T cells during treatment on the study, they will receive an antibody drug called an immune checkpoint inhibitor, pembrolizumab or nivolumab. Immune checkpoint inhibitors are drugs that remove the brakes on the immune system to allow it to act against cancer.
CONDITIONS
Official Title
HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HER2-positive sarcoma with at least grade 1 and 1+ intensity HER2 staining
- Age between 1 and 25 years
- Karnofsky or Lansky performance score of 60 or higher
- Signed informed consent by patient or guardian
- Active disease progression or recurrence after at least one prior systemic therapy
- At least 4 weeks recovered from prior cytotoxic chemotherapy or 7 days/3 half-lives from targeted drugs
- Normal cardiac left ventricular function by echocardiogram
- Total bilirubin ≤1.5x upper limit of normal and direct bilirubin ≤ upper limit of normal
- AST/ALT ≤ 2.5x upper limit of normal
- Serum creatinine ≤1.5x upper limit of normal
- Hemoglobin ≥7.0 g/dL (transfusion allowed)
- White blood cell count >2,000/µl
- Absolute neutrophil count >1,000/µl
- Platelets >75,000/µl (not transfused)
- Pulse oximetry ≥90% on room air
- Sexually active males and females of childbearing potential must agree to use effective contraception
- Available autologous transduced T cells with ≥15% HER2 CAR expression and ≥20% killing of targets
- Signed informed consent by patient or guardian
You will not qualify if you...
- Known HIV positivity
- Severe previous toxicity from cyclophosphamide or fludarabine
- Severe hypersensitivity (≥Grade 3) to pembrolizumab, nivolumab, or their excipients
- History of allergic reactions to murine protein products, DMSO, or dextran 40
- Active cardiac disorder or abnormal heart function
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of non-infectious pneumonitis requiring steroids or current pneumonitis
- Known active tuberculosis
- Solid organ transplantation history
- Immunodeficiency or immunosuppressive therapy other than cytotoxic chemotherapy
- Presence of bulky tumor at primary or metastatic site
- Intercurrent infection
- Pregnant or lactating
- Received live virus vaccine within 30 days
- Received radiotherapy within 14 days of trial treatment (except limited palliative radiation)
- Any condition or abnormality making participation not in patient's best interest as determined by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Meenakshi Hegde, MD
CONTACT
B
Brandon Garner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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