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© 2019 by Global Healthcare Direct Limited

Anti-GD2 CAR-T Treatment for Solid Tumors

Phase I/II Clinical Trial

Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex multi-model therapy and therefore, novel approaches are urgently needed. The trial willt 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.

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 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.

Phase I/II Open Clinical Trial 

Through both our partner hospital in Beijing and the trial sponsor, Shenzhen Geno-immune Medical Institute, Global Healthcare Direct provides access to the clinical trial recruitment process. 

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 100 participants
Masking: Open-label trial
Primary Purpose: Treatment

Common Indiactions: 

  • Brain Cancer (Neuroblastoma and Brain Gliomas)

  • Bladder cancer

  • Prostate cancer

  • Cervical cancer

  • GD2 positive tumours: Neuroblastoma, Melanoma, Sarcoma, Small cell lung cancer, etc.

How to apply for the Solid Tumor CAR-T trial?

Fill in the below form. Add a short description of your case history and of your current condition. Our case manager will contact you shortly and guide you through.

Choosing to participate in a phase I/II medical trial is an important personal decision.

Talk with your doctors and family members or friends about deciding to join a study!

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Eligibility 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 / ECOG grade 2 or lower

  • 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

  • Karnofsky/jansky score of 50% or lower / ECOG grade 3 or higher

  • 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.

What's next?

  1. Contact us: fill this form, send an email or give us a call.

  2. Send us your medical documents. We will translate and forward them to the hospital's experts.

  3. We will send you the various possible treatment plans and prices, and help you select the best option for you.

  4. If you’d like, we can help in organizing your flights and accommodation.

  5. Our personal attendant will meet you at the arrival gate and accompany you throughout the course of your treatment.

  6. We will send the translated release documents and keep in touch with you even after you leave.

 

Always here for you,

The GHD Team 

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