Study on GD2 Positive Solid Tumors by 4SCAR-GD2

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID: NCT02992210
Run by: Shenzhen Geno-Immune Medical Institute
People needed: 100
Starts: 2025-05-01
Expected to finish: 2029-12-01
Last updated by the study team: 2025-09-08

Who can join

Age: 1 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity.
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.
Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
Patients who require systemic corticosteroid or other immunosuppressive therapy.
Evidence of tumor potentially causing airway obstruction.
Inability to comply with protocol requirements.
Insufficient CAR T cells availability.

Where it is running

Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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