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Tests treatment safety and results for Sarcoma
Official title Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
ClinicalTrials.gov ID: NCT03356782
What this study is testing
What is Sarcoma-specific CAR-T cells?
Sarcoma-specific CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sarcoma.
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 aim of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines CAR T cells and IgT cells to treat sarcoma.
- Phase 2: a mid-size study of how well it works
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 75
You may be able to join if
- Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;
- Age: ≥ 18 and ≤65 years of age at the time of enrollment;
- At least 4 weeks since any chemotherapy or radiotherapy and at least 1 week since immunosuppressive therapy such as using steroid hormone before...
- Side effects of chemotherapy have been well managed;
- Malignant cells are target antigen positive(higher than ++) confirmed by IHC, quantitative PCR or sequencing;
You likely can't join if
- The disease is progresseing rapidly;
- The patient is receiving therapy of other new drugs;
- Evidence of tumor potentially causing airway obstruction;
- Epilepsy history or other CNS diseases;
- Patients who need immunosuppressive drugs because of GVAD;
- History of long QT syndrome or severe heart diseases;
See the full eligibility criteria
- Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;
- Age: ≥ 18 and ≤65 years of age at the time of enrollment;
- At least 4 weeks since any chemotherapy or radiotherapy and at least 1 week since immunosuppressive therapy such as using steroid hormone before enrollment;
- Side effects of chemotherapy have been well managed;
- Malignant cells are target antigen positive(higher than ++) confirmed by IHC, quantitative PCR or sequencing;
- Karnofsky /jansky score of 50% or greater;
- Expected survival \> 6 weeks;
- ANC≥ 1×10\^6/L，PLT ≥ 1×10\^8/L;
- Pulse oximetry of≥90% on room air；
- Adequate hepatic function,defined as aspartate aminotransferase(AST)\< 5 times upper limit of normal(ULN),serum bilirubin \< 3 times ULN;
- Adequate renal function,defined as serum creatinine less than 2 times ULN,if serum creatinine more than 1.5 times ULN,creatinine clearance rate test is needed;
- Patients must have autologous transduced T cells at levels greater than 15%;
- Sign an informed consent and assent.
- The disease is progresseing rapidly;
- The patient is receiving therapy of other new drugs;
- Evidence of tumor potentially causing airway obstruction;
- Epilepsy history or other CNS diseases;
- Patients who need immunosuppressive drugs because of GVAD;
- History of long QT syndrome or severe heart diseases;
- Uncontrolled active infection;
- Active hepatitis B virus,hepatitis C virus and HIV infection;
- Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids;
- Previous treatment with any gene therapy;
- Creatinine\>2.5mg/dl or ALT/AST\>3 times normal or bilirubin\>2.0 mg/dl;
- Patients who have other uncontrolled diseases would preclude participation as outlined;
- Pregnant or lactating women;
- Patients previously experienced toxicity from cyclophosphamide;
- Patients who have CNS sarcoma;
- In condition that may bring risks to people or interference to clinical trials.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. 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.