Tests GD2-targeted engineered T cells in people with solid tumors
Tests genetically modified T cells against GD2 in refractory or recurrent solid tumors.
Plain-language title generated from the registry record
Registry title: Study on GD2 Positive Solid Tumors by 4SCAR-GD2
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 people aged 1 to 65 whose solid tumor has not responded to standard first treatment, has spread, progressed or come back, and whose tumor shows the GD2 marker.
- Age
- 1 year to 65 years
- Sex
- All sexes can join.
- Disease stage
- Solid tumor that cannot be removed by surgery, has spread, is getting worse or has come back after standard first-line treatment.
- Earlier treatment
- Standard first-line therapy must have been given. There is no limit on the number of earlier treatments. Waiting times are required after growth factors, targeted or biologic drugs, monoclonal antibodies and radiation.
- Biomarker or test result
- The tumor must be GD2 positive, shown by antibody staining (immunohistochemistry) or flow cytometry.
Main reasons for not taking part
- Severe illness or major organ dysfunction (grade 3 blood toxicity excepted)
- Untreated brain or spinal cord (CNS) spread of the tumor
- Earlier treatment with other genetically engineered GD2 CAR T cells
- Active HIV, hepatitis B or hepatitis C infection, or uncontrolled infection
- Need for steroid or other immune-suppressing treatment
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 65 years old?
Source: NCT02992210, 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
- NCT02992210
- Record updated
- 30 October 2026
- Original description
Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. The investigators are attempt to treat these diseases using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9 domain) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill tumor cells through the recognition of GD2, a surface protein expressed at high levels on many types of tumors but not on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent tumors.Read full original descriptionShow less
Multicenter Trial of Phase I/II Studies on GD2 Positive Solid Tumors by 4SCAR-GD2
Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. The investigators are attempt to treat these diseases using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9 domain) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill tumor cells through the recognition of GD2, a surface protein expressed at high levels on many types of tumors but not on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent tumors.
Inclusion: Patients with tumors have received standard first-line therapy and been judged to be non-resectable，metastatic,progressive or recurrent; The GD2 antigen status of the tumor will be determined for eligibility.Positive expression is defined by GD2 antibody staining results based on immunohistochemistry or flow cytometry analyses; Body weight greater than or equal to 10 kg; Age: ≥1 year and ≤ 65 years of age at the time of enrollment; Life expectancy: at least 8 weeks; Prior Therapy: 1) There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less. 2) Must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 3) At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic nonmyelosuppressive regimen. 4) At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 5) At least 1 weeks since any radiation therapy at the time of study entry; Karnofsky/jansky score of 60% or greater; Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent ; Pulse Ox greater than or equal to 90% on room air; Liver function: defined as alanine transaminase (ALT) <3x upper limit of normal (ULN), aspartate aminotransferase (AST) <3x ULN; serum bilirubin and alkaline phosphatase <2x ULN; Renal function: Patients must have serum creatinine less than 3 times upper limit of normal; Marrow function: White blood cell count ≥1000/ul, Absolute neutrophil count ≥500/ul, Absolute lymphocyte count ≥500/ul, Platelet count ≥25,000/ul (not achieved by transfusion); Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease not evaluable for hematologic toxicity; For all patients enrolled in this study, their parents or legal guardians must sign an informed consent and assent.
Exclusion: Untreated central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible; Previous treatment with other genetically engineered GD2-CAR T cells; Patients who require systemic corticosteroid or other immunosuppressive therapy; Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity; Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection; Evidence of tumor potentially causing airway obstruction; Inability to comply with protocol requirements; Insufficient CAR T cells availability.