Tests GD2/CD70 bispecific CAR-T cells in cancers with GD2 or CD70 markers
Tests modified T cells targeting GD2 and CD70 in patients with cancer.
Plain-language title generated from the registry record
Registry title: GD2/CD70 Bi-specific CAR-T Cell Therapy
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 with a tumor that has GD2 and/or CD70 on its cells and that cannot be removed by surgery, has spread, is growing or has come back after standard first-line treatment.
- Age
- From 1 year to 75 years old.
- Sex
- All sexes can join.
- Disease stage
- Tumor that cannot be removed by surgery, has spread, is progressing or has returned. Life expectancy of at least 8 weeks.
- Earlier treatment
- Standard first-line therapy must have been given. There is no limit on the number of earlier treatments. At least 4 weeks since a monoclonal antibody, at least 7 days since a biologic or targeted agent, and at least 1 week since radiation. No growth factors for at least 1 week before the cell collection.
- Biomarker or test result
- The tumor tissue must show GD2 or CD70 on testing (immunohistochemistry or flow cytometry).
Main reasons for not taking part
- Severe illness or major organ problems, or marked blood count toxicity
- Brain or spinal cord tumor spread that cannot be treated
- Earlier treatment with GD2 or CD70 CAR T cells
- Active HIV, hepatitis B, hepatitis C or uncontrolled infection
- Need for steroids or other drugs that weaken the immune system
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: NCT05438368, 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
- NCT05438368
- Record updated
- 2 November 2026
- Original description
The purpose of this study is to assess the feasibility, safety and efficacy of GD2/CD70 bi-specific CAR-T cell therapy in patients with GD2 and/or CD70 positive tumor. Another goal of the study is to learn more about the function of the GD2/CD70 bi-specific CAR-T cells and their persistency in patients.Read full original descriptionShow less
GD2/CD70 Bi-specific CAR-T Cells for Cancer Treatment
The purpose of this study is to assess the feasibility, safety and efficacy of GD2/CD70 bi-specific CAR-T cell therapy in patients with GD2 and/or CD70 positive tumor. Another goal of the study is to learn more about the function of the GD2/CD70 bi-specific CAR-T cells and their persistency in patients.
Inclusion: Patients with tumors received standard first-line therapy and judged to be non-resectable, metastatic, progressive or recurrent; The expression status of GD2 or CD70 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses; Body weight greater than or equal to 10 kg; Age: ≥1 year and ≤ 75 years of age at the time of enrollment; Life expectancy: at least 8 weeks; Prior Therapy:; There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must be resolved to grade 2 or less; Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection; At least 7 days must have elapsed since the completion of therapy with a biologic agent, selected targeted agent or a metronomic non-myelosuppressive regimen; At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody; At least 1 week 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 does not have hematologic toxicity; For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent.
Exclusion: Untreatable 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 or CD70-specific 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, or greater than grade 2 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.