Immunotherapy Combination Trial for Relapsed or Advanced Sarcoma
Tests CAR-T cells followed by vaccines in people with returned or advanced sarcoma.
Plain-language title generated from the registry record
Registry title: Combination Immunotherapy Targeting Sarcomas
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
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: NCT04433221, 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
- NCT04433221
- Record updated
- 2 November 2026
- Original description
The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and 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 multiple CAR T cells followed by sarcoma vaccines.Read full original descriptionShow less
Safety and Efficacy Evaluation of a Combination Immunotherapy Targeting Sarcomas
The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and 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 multiple CAR T cells followed by sarcoma vaccines.
Inclusion: Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients; Age: ≥ 6 months and ≤80 years of age at the time of enrollment; At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment; Side effects of chemotherapy have been well managed; Confirmed malignant cell expression of CART target antigens by IHC or flow; Karnofsky /jansky score of 50% or greater; Expected survival > 8 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 sufficient autologous CART cells at does greater than 0.5x10\^6 cells/kg body weight; Sign an informed consent and assent.
Exclusion: The patient is receiving therapy of other new drugs and under evaluation; Patients who need immunosuppressive drugs; Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids; Previous treatment with any gene therapy; Patients previously experienced toxicity from cyclophosphamide and doxorubicin; The disease is progressing rapidly; Epilepsy history or other CNS diseases; Uncontrolled active infection; Active hepatitis B virus, hepatitis C virus or HIV infection; Patients who have other uncontrolled diseases such as obstruction of lung function 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.