Tests CAR T cell therapy in people with relapsed or late-stage sarcoma
Tests engineered CAR T cells in people with sarcoma that has returned or spread.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced (stage 3 or 4) or returned sarcoma whose tumour cells carry the target marker, to test CAR T cell therapy.
- Age
- 18 to 65 years at enrollment
- Sex
- All sexes can join
- Disease stage
- Stage 3 or 4 sarcoma, or sarcoma that has come back
- Earlier treatment
- At least 4 weeks since any chemotherapy or radiotherapy. At least 1 week since immunosuppressive therapy such as steroid hormone. Side effects of chemotherapy must be well managed. No previous gene therapy.
- Biomarker or test result
- Tumour cells must be positive for the target antigen (higher than ++), confirmed by IHC, quantitative PCR or sequencing. The patient's own modified T cells must be above 15%.
Main reasons for not taking part
- Rapidly progressing disease
- Active hepatitis B, hepatitis C or HIV infection, or other uncontrolled infection
- Epilepsy history, other central nervous system disease, or sarcoma in the central nervous system
- History of long QT syndrome or severe heart disease
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 75 years old?
Source: NCT03356782, who can take part
Where in China
- Shenzhen Geno-immune Medical InstituteShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Geno-Immune Medical Institute
- Trial code
- NCT03356782
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
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.
Inclusion: 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.
Exclusion: The patient is receiving therapy of other new drugs; Patients who need immunosuppressive drugs because of GVAD; Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids; Previous treatment with any gene therapy; Patients previously experienced toxicity from cyclophosphamide; The disease is progresseing rapidly; Epilepsy history or other CNS diseases; Uncontrolled active infection; Active hepatitis B virus,hepatitis C virus and HIV infection; Patients who have other uncontrolled diseases would preclude participation as outlined; In condition that may bring risks to subjects or interference to clinical trials; History of long QT syndrome or severe heart diseases; Creatinine>2.5mg/dl or ALT/AST>3 times normal or bilirubin>2.0 mg/dl; Evidence of tumor potentially causing airway obstruction; Pregnant or lactating women; Patients who have CNS sarcoma.