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New treatment option for Sarcoma
Official title HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma
ClinicalTrials.gov ID: NCT04995003
What this study is testing
What is T cells or CAR T cells?
T cells or CAR T cells is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for sarcoma.
Also referred to as HER2 CAR T cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- Procurement
- Diagnosis of a HER2-positive sarcoma. Immunohistochemistry (IHC) will be used to determine HER2 expression. Standard HER2 positive breast cancer...
- Age between 1 to 25 years
- Karnofsky or Lansky performance score of ≥ 60
- Informed consent explained to, understood by, and signed by patient/guardian. Patient or guardian given copy of informed consent. Treatment
You likely can't join if
- Known HIV positivity
- Severe previous toxicity from cyclophosphamide including, but not limited to, decreased heart function, abnormal heart rhythms, severe allergic...
- Severe previous toxicity from fludarabine including, but not limited to, neurotoxicity, coma, renal injury requiring dialysis, development of...
- Severe hypersensitivity (≥Grade 3) to pembrolizumab or nivolumab or any of their excipients
- History of allergic reactions attributed to murine protein containing products, DMSO or dextran 40
- Known, active cardiac disorder defined as left ventricular ejection fraction below the institution normal as determined by echocardiogram or New York...
See the full eligibility criteria
Who can join
- Procurement
- Diagnosis of a HER2-positive sarcoma. Immunohistochemistry (IHC) will be used to determine HER2 expression. Standard HER2 positive breast cancer density gradient tissue microarrays will be used as positive controls...
- Age between 1 to 25 years
- Karnofsky or Lansky performance score of ≥ 60
- Informed consent explained to, understood by, and signed by patient/guardian. Patient or guardian given copy of informed consent. Treatment
- Diagnosis of a HER2 positive sarcoma with active disease progression or recurrence after at least one prior systemic therapy
- At least 4 weeks from and having recovered from acute toxic effects of all prior cytotoxic chemotherapy. Those receiving targeted (non-cytotoxic) drugs must be at least 7 days or 3 drug half-lives, whichever is greater...
- Normal cardiac left ventricular end diastolic function (LVEF) as measured by echocardiogram (normal per institutional limits)
- Karnofsky or Lansky performance score of ≥60
- Total bilirubin ≤1.5x upper limit of normal (ULN) for age AND direct bilirubin ≤ULN for age
- AST/ALT ≤ 2.5x ULN
- Serum creatinine ≤1.5x ULN for age
- Hgb ≥ 7.0 g/dL (transfusion allowed)
- WBC \> 2,000/µl
- ANC \>1,000/ul
- Platelets \>75,000/ul (not transfused)
- Pulse oximetry of ≥ 90% on room air
- Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator. Non-childbearing potential is defined as...
- Available autologous transduced cytotoxic T lymphocytes with ≥ 15% expression of HER2 CAR and killing of HER2-positive targets ≥ 20% in cytotoxicity assay
- Informed consent explained to, understood by, and signed by patient or guardian. Patient or guardian given copy of informed consent. Procurement
What rules you out
- Known HIV positivity
- Severe previous toxicity from cyclophosphamide including, but not limited to, decreased heart function, abnormal heart rhythms, severe allergic reaction, or grade 4 hemorrhagic cystitis
- Severe previous toxicity from fludarabine including, but not limited to, neurotoxicity, coma, renal injury requiring dialysis, development of hemolytic anemia, or development of a secondary malignancy
- Severe hypersensitivity (≥Grade 3) to pembrolizumab or nivolumab or any of their excipients
- History of allergic reactions attributed to murine protein containing products, DMSO or dextran 40
- Known, active cardiac disorder defined as left ventricular ejection fraction below the institution normal as determined by echocardiogram or New York Heart Association (NYHA) functional class III or IV or clinically...
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin...
- History of non-infectious pneumonitis that required steroids or current pneumonitis
- Known history of active tuberculosis
- Has undergone solid organ transplantation at any time
- Has a diagnosis of immunodeficiency or is receiving any other form of immunosuppressive therapy aside from cytotoxic chemotherapy
- Presence of bulky tumor at the primary or metastatic site
- Has a history or current evidence of any condition, therapy, or laboratory or radiologic abnormality that is not in the best interest of the subject to participate, as determined by the treating investigator Treatment...
- Known HIV positivity
- Intercurrent infection
- Pregnant or lactating
- History of hypersensitivity to murine protein-containing products, DMSO or dextran 40
- Severe previous toxicity from cyclophosphamide including, but not limited to, decreased heart function, abnormal heart rhythms, severe allergic reaction, or grade 4 hemorrhagic cystitis
- Severe previous toxicity from fludarabine including, but not limited to, neurotoxicity, coma, renal injury requiring dialysis, development of hemolytic anemia, or development of a secondary malignancy
- Severe hypersensitivity (≥Grade 3) to pembrolizumab or nivolumab or any of their excipients
- Cardiac disorder defined as left ventricular ejection fraction below the institution normal as determined by echocardiogram or New York Heart Association (NYHA) functional class III or IV or clinically significant...
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin...
- History of non-infectious pneumonitis that required steroids or current pneumonitis
- Known history of active tuberculosis
- Has received a live virus vaccine within previous 30 days
- Has undergone solid organ transplantation at any time
- Has a diagnosis of immunodeficiency or is receiving any other form of immunosuppressive therapy
- Presence of bulky tumor at the primary or metastatic site
- Has received radiotherapy within 14 days of start of trial treatment with the exception that those who have received palliative radiation (≤ 10 days of radiotherapy) to non-central nervous system disease within 7 days...
- Has a history or current evidence of any condition, therapy, or laboratory or radiologic abnormality that is not in the best interest of the subject to participate, as determined by the treating investigator
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.