Who may be eligible for the Study on GD2 Positive Solid Tumors by 4SCAR-GD2 trial?

Inclusion Criteria: * 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 Criteria: * 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.

ClinicalTrials.gov record NCT02992210

Study on GD2 Positive Solid Tumors by 4SCAR-GD2

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 25, 2026

Multicenter Trial of Phase I/II Studies on GD2 Positive Solid Tumors by 4SCAR-GD2

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).

Age1 year old to 65 years old

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1/2 trial studies 4SCAR-GD2 CAR T cells in people with refractory or recurrent GD2-positive solid tumors. Participants provide blood cells that are modified in the lab to express the 4SCAR-GD2 receptor, receive a short chemotherapy conditioning regimen, then are given the modified T cells. The study will evaluate side effects and seek the appropriate dose.

What it is studying. The study is testing the safety, side-effect profile, and appropriate dose of 4SCAR-GD2 genetically modified T cells in people with refractory or recurrent GD2-positive solid tumors, and will also collect data on anti-tumor effects and immune responses.

What the researchers hope to learn. Scientifically, the study aims to determine the toxicity profile and recommended dose of 4SCAR-GD2 CAR T cells, measure anti-tumor activity, monitor expansion and persistence of the CAR T cells in blood, assess immune responses after infusion (lymphocyte phenotypes and cytokine profiles), and evaluate progression-free and overall survival.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Genetic: 4SCAR-GD2

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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 criteria

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Important Regulatory Notice ： This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China. ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities. Background: Patients with refractory and/or recurrent solid tumors have poor prognosis despite complex multimodal therapy; therefore, novel curative approaches are needed. The investigators are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a 4th generation GD2-specific chimeric antigen receptor (4SCAR-GD2). The chimeric antigen receptor (CAR) molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, GD2, which is expressed at high levels on tumor cells but not at significant levels on normal tissues. This study will evaluate the side effects and the best dose of a novel 4th generation anti-GD2 CAR T cells to refractory and/or recurrent solid tumors. Design: Participants will be screened through physical exam and medical history. Blood and urine samples will be collected. Imaging studies or bone marrow aspirates may be performed. Peripheral blood mononuclear cells (PBMC) will be obtained by apheresis, and T cells will be activated and modified to express the 4SCAR-GD2 gene. On Day -5 to -7, PBMC will be activated and enriched for T cells, which will be followed by 4SCAR-GD2 lentiviral transduction. The total culture time is approximately 5-7 days. Participants will receive a preparative conditioning regimen comprising cyclophosphamide/fludarabine to prepare their immune system to accept the modified CAR T cells.The preparative regimen will be based on patient immune condition and consistent with standard chemotherapy conditioning regimen.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would have screening visits with a physical exam, medical history, and blood and urine samples; imaging tests or a bone marrow aspirate may also be done. T cells would be collected from your blood by apheresis, activated and genetically modified in the lab with the 4SCAR‑GD2 CAR (a process taking about 5–7 days), and then given back to you as an infusion after a short preparative chemotherapy regimen (cyclophosphamide and fludarabine). After the infusion, the study team will do blood tests to monitor CAR T cell levels and side effects, and may use scans or other tests to assess your disease status.

How the study is structured. This is an interventional, single-group Phase 1/2 study with no masking. Participants are screened with a physical exam, medical history, blood and urine samples, and possibly imaging or bone marrow aspirate. Peripheral blood mononuclear cells are collected by apheresis; T cells are activated and transduced with the 4SCAR-GD2 lentiviral construct (culture time about 5–7 days). Before receiving the modified cells, participants get a preparative conditioning regimen of cyclophosphamide and fludarabine tailored to their immune status. Follow-up assessments will track adverse events, tumor status, CAR T cell levels, immune responses, and survival over the study timeframes listed in the registry.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Solid Tumor. Does it apply to my diagnosis?
This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Dec 31, 2026 (estimated)
Primary completion: June 2028 (estimated)
Study completion: December 2029 (estimated)
Target enrollment: 10 participants (estimated)
Last updated on registry: Aug 24, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Shenzhen Geno-Immune Medical Institute
Principal investigator: Lung-Ji Chang, Director
Shenzhen Geno-Immune Medical Institute

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Lung-Ji Chang, PhD. 📞 +86 0755-86573763 ✉ c@szgimi.org

Participating sites (1)

Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000 · China
- Lung-Ji Chang, PhD · +86-13671121909 · c@szgimi.org

Terms used on this page · explanations by MedicalUpdates.ai

refractory: A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
chimeric antigen receptor: A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Life expectancy: Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
Prior Therapy: Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
Karnofsky: A scale from 100 (no complaints) down to 0 that describes how well a person can carry out daily activities. Studies often require a minimum score.
upper limit of normal: The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Absolute neutrophil count: The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
assent: A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
corticosteroid: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
immunosuppressive: A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
sponsor: The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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